Sei sulla pagina 1di 114

Study of the Anti-Diabetic Market and

Doctors Perception Regarding the Drugs


Used in Diabetes Mellitus
Dissertation Submitted to the
Padmashree Dr. D.Y. Patil University In partial fulfillment of
the requirements for the award of the Degree
MASTERS IN BUSINESS ADMINISTRATION
Submitted by:
Swapnil Rathore
(Roll No.MB A-P H-012025)

Research Guide
Mr. Nimish Deshpande
Asst. Professor
Department of Business Management
Padmashree Dr. D.Y. Patil University
CBD Belapur, Navi Mumbai
March 2014

DECLARATION

I, Swapnil Rathore hereby declare that the dissertation Study of the Anti-Diabetic
Market and Doctors Perception Regarding the Drugs Used In Diabetes Mellitus
submitted for the MBA Degree at Padmashree Dr. D.Y. Patil Universitys
Department of Business Management is my original work and the dissertation has
not forme d the basis for the award of any degree, associate ship, fellows hip or any
other similar titles.

Place: Mumbai
Date:

Signature of the Student


SWAPNIL RATHORE

CERTIFICATE
This is to certify that the dissertation entitled To study the anti- diabetic
market to study the doctors perception regarding the drugs used in diabetes. is
the bonafide research work carried out by Mr.Swapnil Rathore student of
MBA, at Padmashree Dr. D.Y. Patil Unive rsity Department of Business
Management during the year 20012-2014, in partial fulfillment of the
require ments for the award of the Degree of Master in Business Management
and that the dissertation has not formed the basis for the award previously of
any degree, diploma, associate ship, fellowship or any other similar title.

Dr. R. Gopal,
Director & HOD

Mr. Nimish Deshpande

Department of Business Management,

(Assistant Professor)

Padmashree Dr. D.Y. Patil University

ACKNOWLEDGEMENT

In the first place, I thank Prof. Mr. Nimish Deshpande, Assistant Prof, Department of
Business Management, Padmashree Dr. D.Y.Patil University, Navi Mumbai for
having given me his valuable guidance for the project. Without his help it would have
been impossible for me to complete the project.
It is a matter of pleasure for me to work on a practical project like Study of the antidiabetic market and doctors perception regarding the drugs used in diabetes .This project
has added value to my theoretical knowledge. I would like to admit my sincere thanks to
the various people from Pharma industry & doctors who have provided me a lot of
information and data many of which I have used in this project and without which this
project could not have been completed.
I would be failing in my duty, if I do not acknowledge with a deep sense of gratitude the
sacrifices made by my parents, and those who helped me in completing project work
successfully.

Place: Mumbai
Date:

Signature of Student

PREFACE

Decision making is a fundamental part of the research process. Decisions regarding that
what you want to do, how you want to do, what tools and techniques must be used for the
successful completion of the project. The topics having aroused my curiosity,
discussions were held with several people in the Pharma sector to understand the
veracity of the above thought process and also understand the real issues of the industry.
Basically when we are playing with computer in every part of life, I used it in my project
not for the ease of my but for the ease of result explanation to those who will read this
project. The project presents the current market scenario of anti-diabetic market .
I had come across several difficulties to make the objectives a reality. I am presenting this
hand carved efforts in black and white. All these aspects then resulted in the
development of the project report titled Study of The Anti-Diabetic Market And
Doctors Perception Regarding The Drugs Used In Diabetes Mellitus.
It is strongly hoped that this project covers not only the various requirements of the
Project Study but also of the Industry.

Signature of the Student

TABLE OF CONTENTS
TABLE OF CONTENTS
EXECUTIVE SUMMARY ................................................................................................. 7
RESEARCH METHODOLOGY......................................................................................... 9
DATA COLLECTION................................................................................................... 10
OBJECTIVE OF THE STUDY ......................................................................................... 13
INDUSTRY DEFINITIONS ............................................................................................. 15
DIABETES IN INDIA....................................................................................................... 16
The Risk Factors for Diabetes in Indians Are:............................................................... 16
Introduction of disease: .................................................................................................. 19
RESEARCH....................................................................................................................... 20
Objectives of research : .................................................................................................. 20
INTRODUCTION ............................................................................................................. 21
Types of Diabetes........................................................................................................... 24
DATA ANALYSIS & DATA INTERPRETATION ........................................................ 83
Data Analysis and Interpretation for Chemist Questionnaire ........................................ 93
CONCLUSION................................................................................................................ 101
LIMITATION OF THE STUDY ..................................................................................... 102
SUGGESTION AND RECOMMENDATION................................................................ 103
APPENDIX ...................................................................................................................... 104
ANNEXURE-I ............................................................................................................. 104
ANNEXURE-II ............................................................................................................ 108
ANNEXURE-III........................................................................................................... 110
ANNEXURE-IV .......................................................................................................... 112
ANNEXURE-V............................................................................................................ 114

EXECUTIVE SUMMARY
Diabetes is the syndrome of having excess blood sugar due to low levels of
insulin or insulin resistance. Approximately 21 million individuals in the U.S. have
diabetes, and this number is growing at 10% a year, or over 1.5 million new cases
annually. According to a new report published by Transparency Market Research .The
Global Market for Diabetes Management accounted for USD 40 billion in 2010 and is
expected to attain a market size of around USD 114 billion following a growth rate of
13.5% CAGR. The major products in this market consists of glucose meters, test strips,
lancets, continuous blood glucose meters, syringes, insulin pumps, insulin and other
insulin delivery devices and anti-diabetic drugs. However, insulin, test strips and antidiabetic drugs are the most revenue generating products.
Market Research is one of the most important function that a company or any
organization performs to identify its environment and adapt according to it .The title of
project is Study of the Anti-Diabetic Market and Doctors Perception Regarding the
Drugs Used In Diabetes Mellitus. The objective of project is to find out the market of anti
spasmodic drugs, and also to find out what are trends of drugs mostly used by physicians.
The project is based on research of anti diabetes drug in market which are available in
market.
The project, the method adapted for primary data collection was survey (through
Questionnaire) method. This method was selected and used as it is extremely flexible and
more or less economic. Also some secondary data was collected through doctors enquiry
and searching on the internet .During this project I had to face vario us problems regarding
the survey responses.
For the collection of primary data on Huminsulin (r) , I take a sample size 50 including
General physician & Diabetalogist .
The communication with doctor during survey concluded that the number of patients are
increasing day by day. one of senior doctor told that initially diabetes was very less as
compared to present. it can be said that the diabetes is increasing in double ratio specially
in old age people.
The survey from all doctor concluded that both type of diabetes patient i.e. non- insulin
dependent diabetes mellitus (NDDM) and insulin dependent diabetes mellitus (IDM)
approach to doctor.
Patients has to regularly monitor glucose level with glucometer like instruments. Diabetes
patient also need to take lot of care in diet and the medicine should be taken from time to
time. The IDDM patient need to take regularly subcutaneous injection of insulin. the
missing of drug dose and carelessness in diet can lead to threatening condition patient
may need to hospitalized.
The doctor also said that the fast food is also responsoible for increasing diabetes
patients. So they advice to take proper calorie food which is needed by patients.
7

.While in case of NIDD doctors like to preffered drug as well as insulin injection. but the
diabetes can be controlled mostly by taking drug tolbutamide, chlorpropmide, metformin,
sitagliptin etc. regularly.
The most doctors said that the cost of treatment is affordable to patient is not sufficient
while few come to conclusion it may or may not be.
The near about 25% doctor said that there is not that much side effect which can be
neglected but there is only need to take proper dose should be given to patients according
to situation. some said there are side effect depend on patient physiology so few doctor
said that side effect can be or not.
The survey concluded that all doctors know about both brands metformin and huminsulin.
They said brands are most commonly prescribed. There is no hesitation in writing these
brands. Both brands have given excellent result. The patient to whom this brands are
prescribed they have given positive response.
No. of patients suffering from diabetes is constantly increasing; India is set to become the
global hub of diabetes in the coming decade. It is more prevalent amongst males.
Prediabetes is a stage between normal and diabetes stage. It is an alarming sign for
upcoming diabetes or a chance to change your future
Type 1 is treated with insulin replacement therapy usually by injection or insulin
pump, along with attention to dietary management, typically including carbohydrate
tracking, and careful monitoring of blood glucose levels using Glucose meters.
Now a days Diabetes is a very common disorder in India as well as through out the wor ld.
Every fifth person is suffered by the diabetes disorder. India is an expanding stage in
Anti-diabetic market. In coming few years India is become the top position for diabetic
patient/Market.
The aged (old) people suffer more towards the diabetes diso rder. There are lots of factors
responsible for diabetes.

RESEARCH METHODOLOGY
Research refers to a search for knowledge. It is a systematic method of
collecting and recording the facts in the form of numerical data relevant to the formulated
problem and arriving at certain conclusions over the problem based on collected data.
Thus formulation of the problem is the first and foremost step in the research process
followed by the collection, tabulation and analysis and drawing the conclusions.

METHODS OF RESEARCH METHODOLOGY


SAMPLING METHOD:
The two major methods are probability and non-probability sampling technique. The
study requires probability method since the sample was chosen. Hence the study involve
choosing the doctors as sample study on the basis of the following factors such as number
of diabetes patients seen on the daily basis, percentage of prescribers of anti diab etes
drug, knowledge regarding diabetes and so on .

SURVEY METHOD
The most widely used technique of gathering primary data is the survey method. The
sources interviewed personally at the place of work and also with questionnaires. It is a
direct and more flexible form of investigation involving face- to- face communication and
through recorded questionnaires filled in personally.

DATA COLLECTION

PRIMARY DATA COLLECTION:


It was collected from the physicians at their clinic by using the questionnaire method and
by survey of chemist.

SECONDARY DATA COLLECTION:


It was collected from the internet, books, journals, articles. Secondary data provides a
better view of the problem study.

Type of Research:
Quantitative Research

Sample size:

50 Physicians and Diabetalogist and 40 chemist.

Sample unit:

Navi Mumbai area

10

INTRODUCTION
Diabetes is a chronic disease that occurs when the pancreas does not
manufacture enough insulin, or alternatively, when the body cannot effectively use the
insulin it produces. Insulin is a hormone that controls the sugar level in the
bloodstream. If the sugar is not converted into energy for the body to use, it builds up.
In the long term, too much sugar, or glucose, in the body can lead to damage to the
heart, blood vessels, eyes, kidneys and nerves. The level of glucose in the blood can
also fluctuate throughout the day and needs to be closely monitored and controlled. As
a direct consequence of the continuing rise in diabetes, the market for diabetes
monitoring and controlling products continues to grow. Diabetes is often closely
associated with the weight condition and general health of an individual. A lack of
regular exercise and tendency toward obesity of the global population will likely drive
up incidence rates of diabetes. This trend is expected to continue as the World Health
Organization (WHO) projects an escalating prevalence worldwide as more cases are
identified. Progress in finding new treatments in care, new products (both therapeutic
and diagnostic), new developments in long-term treatments, and maturing public health
priorities will continue to create new shifts in the diabetes care industry. No. of patients
suffering from diabetes is constantly increasing; India is set to become the global hub
of diabetes in the coming decade. It is more prevalent amongst males. Calorie rich
diet, obesity and genetic factors are considered to be the main factors responsible
for diabetes. Precautions that doctors recommend would be important to note.
Due to the growing incidence and chronic nature of the disease, a drift
towards Ayurvedic and other alternate forms of medicine may be occurring. The
current shift, if any, may foretell trends. Diabetes gives rise to a host of other
complications. Knowing their incidence can give valuable inputs for coprescription, parallel prescription, product development/ improvement/ combinations
etc.
Dibetes has become very much a lifestyle disease in the metros with the
number of patients, especially in the younger age groups, sharply increasing. Thus,
knowing doctors opinions (GPs and Specialists) on the same can give valuable
insights as to the current trends. Diabetes gives rise to a host of other complications.
Knowing their incidence can give valuable inputs for co-prescription, parallel
prescription, product development/ improvement/ combinations etc.
Diabetes has become very much a lifestyle disease in the metros with the
number of patients, especially in the younger age groups, sharply increasing. Thus,
knowing doctors opinions (GPs and Specialists) on the same can give valuable
insights as to the current trends.
The main idea of the project is know how Anti-diabetic market going through
there in the basis of improved research and development. This project give the analysis
11

of Indian Anti-diabetic market and also indicates that it is in booming stage Finally it
also the aim the Indian pharma industry is one of the competitive industry in the Indian
market as well as world market like China, US etc.

12

OBJECTIVE OF THE STUDY


1) Analysis of prescription trends of Insulin.
2) Analysis of chemist sales of Insulin
Limitation of project:In recent year's diabetes drug market and insulin market has shown
remarkable growth. This growth is mostly driven by increasing prevalence o f
diabetes globally and easily availability of insulin in every country due to its access
at an affordable price. The diabetes prevalence is increasing due to changing food
habits in the western world leading to obesity.
As the prevalence of obesity and related diseases (diabetes) has increased,
so have the sales of drugs to treat them. Diabetic Division is a booming division in
Pharma industry so lot of competition in pharma industry it is part of difficulties to
collecting data .The limitation of the study is that small no. of sample siz
Market Structure:Diabetes affects at least 180 million people worldwide and is increasing, with the WHO
predicting 300 million diabetics by 2025. The United States alone has 20.8 million
people suffering from diabetes, equaling 6% of the population. Diabetes is currently
ranked sixth as a cause of death in the U.S.
There is no single remedy for diabetes. Likewise there is no cure. Most
treatments are multi-pronged a focus on a healthy, controlled diet, regular exercise and
use of medications. As the disease progresses, regular daily injections of insulin may be
required. The diabetes care industry is divided into several categories. First is the
medication and pharmaceutical industry which covers the types of medication used
including insulin, insulin storage and its administration.
There is also a significant business in medications to prevent the progress of
the disease. These include Alternative Insulin Delivery Systems as well as a range of
Oral Anti Diabetics (OADs) on the other.
Secondly, the dietary supplement industry has also impacted the diabetes
products market. Various pro diabetic food items, such as diabetic ice creams, pastries,
etc. are available in the market. Finally, exercise, yoga and other alternative therapies
have also been embraced by the diabetes care industry. Significant emphasis has been
placed on the importance of a healthy exercise regimen for patients suffering from
diabetes.
As part of a diabetes care program, an individual with diabetes also
needs access to monitoring supplies such as test strips and blood glucose measuring
hand-held meters. This has boosted the production of various monitoring equipment
and other pathological infrastructure items assisting the diagnosis and sustained
treatment of diabetes.
13

Diabetes
treatment
is expensive.
According
to the
American Diabetes Association, people who have this disease spend an average of
$13,243 a year on health care expenses. Hence the need for insurance plan that
covers as many diabetes-related expenses as possible. This has caused a further
challenge for the healthcare environment. An individual with diabetes can be
confronted with trouble in obtaining and keeping health insurance and life
insurance. Approximately 21 million American children and adults are victims of
diabetes, but a significant share of these are uninsured and cannot gain access to the
supplies, medications, and education necessary to effectively handle the disease.

14

INDUSTRY DEFINITIONS
Hypoglycemia - a condition that occurs when blood glucose is lower than
normal,
usually less than 70 mg/dL. Signs include hunger, nervousness, shakiness, perspiration,
dizziness or light- headedness, sleepiness, and confusion.
Hype rglycemia a condition of excessive blood glucose. Fasting hyperglycemia is
blood glucose above a desirable level after a person has fasted for at least 8 hours.
Diabetes insipidus - A condition characterized by frequent and heavy urination,
excessive thirst and an overall feeling of weakness. This condition may be caused
by a defect in the pituitary gland or in the kidney. In diabetes insipidus, blood
glucose levels are normal.
Diabetes mellitus - A condition characterized by hyperglycemia resulting from the
body's inability to use blood glucose for energy.
Type 1 Diabetes - In Type 1 diabetes, the pancreas no longer makes insulin and
therefore blood glucose cannot enter the cells to be used for energy.
Type 2 Diabetes - In Type 2 diabetes, either the pancreas does not make enough
insulin or the body is unable to use insulin correctly
Fasting blood glucose - A method for learning how much glucose (sugar) there is in
a blood sample taken after an overnight fast. The fasting blood glucose test is
commonly used in the detection of diabetes mellitus. The normal, range for blood
glucose is from 70 to 110 mg/dl, depending on the type of blood being tested. If the
level is over 140 mg/dl, it usually means the. Person has diabetes (except for newborns
and some pregnant women).

Insulin - a hormone that regulates the amount of glucose (sugar) in the blood and is
required for the body to function normally. Cells in the pancreas, called the islets of
Langerhans, produce insulin.
Blood glucose monitoring - checking blood glucose level on a regular basis in order to
manage diabetes is called blood sugar monitoring. A blood glucose meter (or blood
glucose test strips that change color when touched by a blood sample) is needed for
frequent blood glucose monitoring.
Thiazolidinedione - a class of oral medications for Type 2 diabetes that helps insulin
take glucose from the blood into the cells for energy by making cells more sensitive to
insulin.
(Generic names: pioglitazone and rosiglitazone)
15

DIABETES IN INDIA
Curre nt Status:Diabetes has emerged as a major healthcare problem in India. According
to Diabetes Atlas published by the International Diabetes Federation (IDF), there were
an estimated 40 million persons with diabetes in India in 2007 and this number is
predicted to rise to almost 70 million people by 2025. The countries with the largest
number of diabetic people will be India, China and USA by 2030. It is estimated that
every fifth person with diabetes will be an Indian. Due to these sheer numbers, the
economic burden due to diabetes in India is amongst the highest in the world. The real
burden of the disease is however due to its associated complications which lead to
increased morbidity and mortality. WHO estimates that mortality from diabetes, heart
disease and stroke costs about $210 billion in India in the year 2005. Much of the heart
disease and stroke in these estimates was linked to diabetes. WHO estimates that
diabetes, heart disease and stroke together will cost about $ 333.6 billion over the next
10 years in India alone?
Rapid urbanization and industrialization have produced advancement on the
social and economic front in developing countries such as India which have resulted in
dramatic lifestyle changes leading to lifestyle related diseases. The transition from a
traditional to modern lifestyle, consumption of diets rich in fat and calories combined
with a high level of mental stress has compounded the problem further. There are
several studies from various parts of India which reveal a rising trend in the prevalence
of type II diabetes in the urban areas. A National Urban Survey in 2000 observed that
the prevalence of diabetes in urban India in adults was 12.1 per cent per cent. Recent
data has illustrated the impact of socio-economic transition occurring in rural India.
The transition has occurred in the last 15 years and the prevalence has risen from 2.4 per
cent to 6.4 per cent.

The Risk Factors for Diabetes in Indians Are:


AgeIndians develop diabetes at a very young age, at least 10 to 15 years earlier than
the western population. An early occurrence of diabetes gives ample time for
development of the chronic complications of diabetes. The incidence of diabetes
increases with age. In India, the life span has increased, hence more number of people
with diabetes are being detected.
Family HistoryThe prevalence of diabetes increases with a family history of
diabetes. The risk of a child developing diabetes with a parental history increases above
50 per cent. A high incidence of diabetes is seen among the first degree relatives.
Indians have a high genetic risk for diabetes as observed in Asian Indians who have
migrated to other countries. They have been found to have a higher rate of diabetes as
compared to the local population .
16

Central ObesityThe association of obesity with Type II Diabetes is well known. Even
with an acceptable body weight range, weight gain could increase the risk of diabetes.
An excess of body fat specially concentrated within the abdomen has an increased risk of
diabetes. The cut-off limit for waist circumference for Indians has been recommended to
be 90 cm for males and 80 cm for females. Abdominal obesity is defined by waist
circumference above these limits.
Physical Inactivity and Sedentary LivingThere is enough evidence to demonstrate
that physical inactivity as a independent factor for the development of type II diabetes.
The availability of motorised transport and a shift in occupations combined with the
plethora of television programmes has reduced the physical activity in all groups of
populations.
Insulin Resistance Asian Indians have been found to be more insulin resistant as
compared to the white population. They have a higher level of insulin to achieve
the same the blood glucose control. A cluster of factors consisting of abnormal fats
(Dyslipidemia), high blood pressure, obesity, and abnormal glucose levels known
as metabolic syndrome is highly prevalent in Asian Indians.
UrbanisationThe developing countries like India are undergoing rapid urbanisation .
Urbanisation is associated with increasing obesity, decreasing physical activity due to
changes in lifestyle, diet and a change from manual work to less physical occupations.
StressThe impact of stress both physical and mental along with lifestyle changes has
a strong effect of increasing incidence of type II Diabetes amongst persons is a strong
genetic background. In a recent study in Chennai, nearly 25 per cent of the population
studied was unaware of a condition called diabetes. Only 40 per cent of the participants
felt that prevalence of diabetes was increasing and only 22 per cent of the population
felt that diabetes could be prevented. Though the awareness levels increased with
education, only 42.6 per cent of postgraduates and professionals including doctors knew
that diabetes was preventable. The knowledge of risk factors was even lower, only 11.9
per cent of the study subjects reported obesity and physical inactivity as risk factors.
Even amongst the known diabetics, only 40.6 per cent were aware that diabetes could
lead to some organ damage and complications. Many people (46 per cent) with diabetes
felt that it was a temporary phenomenon.
In a study in 1998, Diabcare Asia Study, it was observed that of all the patients with
diabetes taking treatment from specialized centers, more than 50 per cent of patients
had poor control of diabetes as per the criteria of American Diabetes Association. The
Study showed that four per cent of patients were on diet therapy alone, 53.9 per cent
were receiving oral antidiabetic agents, 22 per cent of the patients were taking insulin
and another 19 per cent were on both insulin and oral drugs. This Study confirmed that
diabetes care in India leaves much to be desired.
In two other studies carried out in Bangalore and South India, it was observed that
majority of patients (70 per cent) were diagnosed by their general practitioners (GP)
17

and 70 per cent of them had approached the GP for some other problem. 90 per cent
of them underwent only Fasting and Post Meal Blood Sugar and Urine Sugar Tests.
Specialized tests such as Glycosylated Hemoglobin (HbA1C), lipid profile, kidney
Function test were undertaken by only four-six percent of patients. Even simple
measurement of blood pressure, weight and examination of feet were not done for
majority of patients.
In India, the lack of proper healthcare infrastructure, rampant ignorance
and absence of clear cut guidelines mean that approach to the management of
diabetes is ad hoc. The lack of awareness among patients and General Practitioners
(GPs) is a key factor in the poor care. There are practically no nurse educators or
diabetic counselors, no podiatrists (foot experts) and very few dieticians who mean
that the treating doctor has no support and has to take the entire burden of caring for
these patients. The patients' inability/unwillingness to pay for this additional support
also hinders the treatment.
Even after the diagnosis, monitoring of diabetes is very poor. Most of the
patients initially visit a doctor and then discontinue their therapy once their symptoms
and controlled. A majority of the patients abandon modern allopathic treatment in
favors of indigenous treatments. Further, more patients with poor control avoid insulin
for fear of injection and belief of addiction of insulin. Hence they keep changing
doctors and hop from one system of treatment to another leading to further
complications and early death. Lack of resources, medical reimbursement and poor
state funding for diabetes is a barrier to quality care often because the patient is unable
to afford the high cost of treatment.
There is ample evidence to suggest that preventive measures to reduce the burden of
diabetes are needed. The US Diabetes Prevention Programme and the Finnish Diabetes
Prevention Programme and the Chinese Study have conclusively proved that lifestyle
modification including weight loss, increased physical activity and dietary changes can
prevent or delay the onset of diabetes. The need of the hour is direct public education
and mass media campaigns, awareness about diabetes and its complications. There is a
need to spread the message that diabetes is preventable and we need to have a
behavioral change to adopt a healthy lifestyle.

18

Introduction of disease:
History and Statistic
Diabetes is not a newly born disease, it has been with human race from
long back but, we came to knew about it in 1552 B.C. Since this period, many of
Greek as well French physicians had worked on it and made us aware of the nature of
disease, organs responsible for it etc. In 1870s, a French physician had discovered a
link between Diabetes and diet intake, and an idea to formulate individual diet plan
came into picture.
Diabetic diet was formulated with inclusion of milk, oats and other fiber
containing foods in 1900-1915. Function of insulin, its nature, along with its use started
from 1920 -1923, discovered by Dr. Banting, Prof. Macleod and Dr .Collip, who were
awarded a Noble prize. In the decade of 1940, it has been discovered that different
organs like kidney and skin are also affected if diabetes is creeping from a long term. A
major turn in this research was in the year 1955, when the oral hypogycemic drugs had
been manufactured. Diabetes was recognized with complete details and its types (Type
1and Type 2 diabetes - that is insulin dependent and non insulin dependent) in the year,
1959. As we know this is one of the old diseases, existing in many individuals and still
on rising charts. Hence, scientists are continuously working to relieve us from it, by
discovering the relevant drugs and making new researches.

19

RESEARCH
Research in common parlance refers to a search for knowledge. Once can
also define research as a scientific and systematic search for pertinent information on a
specific topic. In fact, research is an art of scientific investigation. The Advanced
Learners Dictionary of Current English lays down the meaning of research as a careful
investigation or inquiry specially through search for new facts in any branch of
knowledge.1 Redman and Mory define research as a systematized effort to gain new
knowledge.2 Some people consider research as a movement, a movement from the
known to the unknown. It is actually a voyage of discovery. We all possess the vital
instinct of inquisitiveness for, when the unknown confronts us, we wonder and our
inquisitiveness makes us probe and attain full and fuller understanding of the unknown.
This inquisitiveness is the mother of all knowledge and the method, which man employs
for obtaining the knowledge of whatever the unknown, can be termed as research.
Research is an academic activity and as such the term should be used in a technical sense.
According to Clifford Woody research comprises defining and redefining problems,
formulating hypothesis or suggested solutions; collecting, organising and evaluating data;
making deductions and reaching conclusions; and at last carefully testing the conclusions
to determine whether they fit the formulating hypothesis. D. Slesinger and M. Stephenson
in the Encyclopaedia of Social Sciences define research as the manipulation of things,
concepts or symbols for the purpose of generalising to extend, correct or verify
knowledge, whether that knowledge aids in construction of theory or in the practice of an
art.3 Research is, thus, an original contribution to the existing stock of knowledge
making for its advancement. It is the persuit of truth with the help of study, observation,
comparison and experiment. In short, the search for knowledge through objective and
systematic method of finding solution to a problem is research. The systematic approach
concerning generalisation and the formulation of a theory is also research. As such the
term research refers to the systematic method.

Objectives of research :
The purpose of research is to discover answers to questions through the
application of scientific procedures. The main aim of research is to find out the truth
which is hidden and which has not been discovered as yet. Though each research study
has its own specific purpose, we may think of research objectives as falling into a number
of following broad groupings:
1. To gain familiarity with a phenomenon or to achieve new insights into it (studies with
this object in view are termed as exploratory or formulative research studies)
2. To portray accurately the characteristics of a particular individual, situation or a group
(studies with this object in view are known as descriptive research studies)
3. To determine the frequency with which something occurs or with which it is associated
with something else (studies with this object in view are known as diagnostic research
studies);
4. To test a hypothesis of a causal relationship between variables (such studies are known
as hypothesis-testing research studies).
20

INTRODUCTION
Sweet has no place in this life. Everyone and everything has turned bitter.
This is the pathetic condition of a diabetic patient. Once detected of diabetes, the world
becomes a bitter one. Hereditary and environmental reasons like lack of exercise and
obesity can be the real cause of this disease. Still the mystery that hovers above the
disease continues. Immense papers are published; the scientific fraternity is toiling day
and night to decipher the exact cause of the disease. The general condition of the body
that does not produce insulin or use it in a proper manner is called diabetes.
Diabetes is a metabolic disorder where in human body does not produce
or properly uses insulin, a hormone that is required to convert sugar, starches, and other
food into energy. Diabetes mellitus is characterized by constant high levels of blood
glucose (sugar). Human body has to maintain the blood glucose level at a very narrow
range, which is done with insulin and glucagon. The function of glucagons is causing
the liver to release glucose from its cells into the blood, for the production of energy
And what is this insulin? Insulin is the hormone that regulates glucose levels in the
blood The FPG (Fasting Plasma Glucose) test or OGTT (Oral Glucose Tolerance Test)
determines whether you are diabetic or not. The FPG test is the more economical,
fastest and easiest test. If the blood sugar level is between 100 and 125mg/dl on the
FPG test then it denotes pre- diabetes and if it is 126mg/dl or above the person suffers
from diabetes. . Desired blood sugar of human body should be between 70 mg/dl -110
mg/dl at fasting state.
If blood sugar is less than 70 mg/dl, it is termed as hypoglycemia and if more than 110
mg /dl, its hyperglycemia Both lead to hyperglycemia where urine is produced
excessively, vision is blurred, lethargy, weight loss, and increased fluid intake. With
the discovery of insulin from 1921, diabetes has become treatable and manageable.
Type 1 diabetes is treated by administering insulin externally either by syringe or
insulin pump. Type 2 is treated by dietary supplements and insulin recommendations.

A hormone that is required to convert sugar, starches, and other food into
energy. Diabetes mellitus is characterized by constant high levels of blood glucose
(sugar).
Human body has to maintain the blood glucose level at a very narrow
range, which is done with insulin and glucagon. The function of glucagons is causing
the liver to release glucose from its cells into the blood, for the production of energy.
There are three main types of diabetes:
Type 1 diabetes
Type 2 diabetes
Gestational diabetes
Type 1 and Type 2 diabetes impede a persons carefree life. When breakdown of
21

glucose is stopped completely, body uses fat and protein for producing the energy.
Due to this mechanism symptoms like polydipsia, polyuria, polyphegia, and
excessive weightloss can be observed in a diabetic.
Diabetes is the primary reason for adult blindness, end-stage renal
disease (ESRD), gangrene and amputations. Overweight, lack of exercise, family
history and stress increase the likelihood of diabetes. When blood sugar level is
constantly high it leads to kidney failure, cardiovascular problems and neuropathy.
Patients with diabetes are 4 times more likely to have coronary heart disease and
stroke. In addition, Gestational diabetes is more dangerous for pregnant women and
their fetus. Though, Diabetes mellitus is not completely curable but, it is controllable
to a great extent.
So, you need to have thorough diabetes information to manage this it
successfully.
The control of diabetes mostly depends on the patient and it is his/her
responsibility to take care of their diet, exercise and medication. Advances in diabetes
research have led to better ways of controlling diabetes and treating its complications.
Hence they include:-

New improved Insulin and its therapy, (external and implantable insulin
pumps)
have advanced well to manage elevated blood sugars without any allergic reactions.
Oral hypoglycemic drug,
controls diabetes type 2.
New improved blood glucose monitor (new device for self blood glucose monitoring),
and hemoglobin A1c laboratory test to measure blood glucose control during previous 3
months. Effective availability of the treatments for affected body organs due to
diabetes.Better ways to manage mother and its fetus health during the gestational
diabetes phase.
Prediabetes
Prediabetes is a stage between normal and diabetes stage. It is an
alarming sign for upcoming diabetes or a chance to change your future. Universally,
numerous terms are given like, Borderline Diabetes, Chemical Diabetes, Touch of
Diabetes etc. The term Prediabetic was given by the US Department of Health And
Human Services and ADA on 27th march 2002 with an intention to create awareness
and convey seriousness of the condition. Also, they motivated people to opt for
appropriate treatment and lifestyle modification.
According to the ADA statistics 17 million US citizens are diabetic and 16 millions are
prediabetic. ADA defines it as a stage before the development of diabetes, with normal
glucose tolerance, but with an increased risk of developing diabetes in near future.
22

Prediabetes is a condition when your blood sugar level triggers higher than normal, but
not so high that we can justify it as type 2 diabetes. According to the Centers for
Disease Control and Prevention,
41 million U.S. adults aged 40 to 74 have prediabetes. And the same reports from, The
American Academy of Pediatrics show that, one of every 10 males and one of every 25
females have prediabetes aged from 12 to 19 years.
Signs and Symptoms of Prediabetes
Prediabetes can take a long time to transform finally as diabetes. It has
been generally observed that prediabetes will eventually convert to diabetes but, at the
same time, there are greater possibilities to revert back to
normal if, taken care seriously. People suffering from prediabetes may show same
symptoms as in diabetes but, they will be erupting occasionally like:
Excessive thirst
Tingling sensations in feet and fingers
Excess-Hunger
Frequent-Urination
Irritability
Frequent infections
Blurred vision
Skin itching
People - In Risk Zone: Some individuals are at more risk of prediabetes than others due
to presence of these factors Being overweight
Family history of prediabetes
Waist hip ratio - The person with 'fat tire'
Depression and stress

Causes: Prediabetic is a person suffering from little high sugar than normal patients.
The reason behind high sugar is entry of glucose into the blood cells due to disturbance
in the mechanism of insulin. Thus, sugar is circulating in the blood stream but unable to
peetrate into cells and tissue, to produce energy. The exact reason for this is uncertain
but it is considered that overweight and fatty tissues along with sedentary lifestyle are
the correlating factors.

23

Types of Diabetes
1) Type 1 diabetes
Diabetes mellitus type 1 (type I diabetes, T1D, T1DM, IDDM, juvenile
diabetes) is a form of diabetes mellitus. Type 1 diabetes is an autoimmune disease that
results in destruction of insulin- producing beta cells of the pancreas. Thus far, such
destruction has been permanent, but there is informed speculation that reversing the
immune system malfunction may allow recovery of beta cell function. Lack of insulin
causes an increase of fasting blood glucose (around 70-120 mg/dL in nondiabetic
people) that begins to appear in the urine above the renal threshold (about 190-200mg/dl
in most people), thus connecting to the symptom by which the disease was identified in
antiquity, sweet urine. Glycosuria or glucose in the urine causes the patients to urinate
more frequently, and drink more than normal (polydipsia). Classically, these were the
characteristic symptoms which prompted discovery of the disease.
Type 1 is lethal unless treated with exogenous insulin. Injection is the
traditional and still most common method for administering insulin; jet injection,
indwelling catheters and inhaled insulin has also been available at various times, and
there are several experimental methods as well. All replace the missing hormone
formerly produced by the now non-functional beta cells in the pancreas.
In recent years, pancreas transplants have also been used to treat type 1
diabetes. Islet cell transplant is also being investigated and has been achieved in mice
and rats, and in experimental trials in humans as well. Use of stem cells to produce a
new population of functioning beta cells seems to be a future possibility, but has yet to
be demonstrated even in laboratories as of 2008.
Type 1 diabetes (formerly known as "childhood", "juvenile" or "insulin- dependent"
diabetes) is not exclusively a childhood problem; the adult incidence of type 1 is
noteworthy many adults who contract type 1 diabetes are misdiagnosed with type 2
due to confusion on this point. There is currently no clinically useful preventive
measure against developing type 1 diabetes, though a vaccine has been proposed and
anti-antibody approaches are also being investigated. Most people who develop type 1
were otherwise healthy and of a healthy weight on onset, but they can lose weight
quickly and dangerously, if not promptly diagnosed. Although the cause of type 1
diabetes is still not fully understood, and diet and exercise may help, the immune
system damage is characteristic of type 1.
The most definite laboratory test to distinguish type 1 from type 2
diabetes is the C-peptide assay, which is a measure of endogenous insulin production
since external insulin has not (to date) included C-peptide. The presence of anti- islet
antibodies (to Glutamic Acid Decarboxylase, Insulinoma Associated Peptide-2 or
insulin), or lack of insulin resistance, determined by a glucose tolerance test, would also
be suggestive of type 1. Many type 2 diabetics continue to produce insulin internally,
24

and all have some degree of insulin resistance.


Pathophysiology
The cause of type 1 diabetes is still not fully understood. Some theorize
that type 1 diabetes is generally a virally triggered autoimmune response in which the
immune system's attack on virus infected cells is also directed against the beta cells in
the pancreas. The autoimmune attack may be triggered by reaction to an infection, for
example by one of the viruses of the Coxsackie virus family or German measles,
although the evidence is inconclusive. In type 1, pancreatic beta cells in the Islets o f
Langerhans are destroyed or damaged sufficiently to effectively abolish endogenous
insulin production. This etiology distinguishes type 1's origin from type 2. It should
also be noted that the use of insulin in treating a patient does not mean that
patient has type 1 diabetes; the type of diabetes a patient has is determined only by the
cause -- fundamentally by whether the patient is insulin resistant (type 2) or insulin
deficient without insulin resistance (type 1) Some researchers believe that the
autoimmune response is influenced by antibodies against cow's milk proteins. A large
retrospective controlled study published in 2006 strongly suggests that infants who
were never breastfed had a risk for developing type 1 diabetes twice that of infants
who were breastfed for at least three months. The mechanism is not fully understood.
No connection has been established between auto antibodies, antibodies to cow's milk
proteins, and type 1 diabetes. A subtype of type 1 (identifiable by the presence of
antibodies against beta cells) typically develops slowly and so is often confused with
type 2. In addition, a small proportion of type 1 cases have the hereditary condition
maturity onset diabetes of the young (MODY) which can also be confused with type 2.
Vitamin D in doses of 2000 IU per day given during the first year of a child's life has
been connected in one study in Northern Finland (where intrinsic production of
Vitamin D is low due to low natural light levels) with an 80% reduction in the risk of
getting type 1 diabetes later in life. The causal connection, if any, is obscure.
Some suggest that deficiency of Vitamin D3 (one of several related
chemicals with Vitamin D activity) may be an important pathogenic factor in type 1
diabetes independent of geographical latitude, and so of available sun intensity. Some
chemicals and drugs preferentially destroy pancreatic cells. Vacor (N- 3-pyridylmethylN'-p-nitrophenyl urea), a rodenticide introduced in the United States in 1976, selectively
destroys pancreatic beta cells, resulting in type 1 diabetes after accidental or intentional
ingestion. Vacor was withdrawn from the U.S. market in 1979, but is still used in some
countries. Zanosar is the trade name for streptozotocin, an antibiotic and antineoplastic
agent used in chemotherapy for pancreatic cancer; it also kills beta cells, resulting in loss
of insulin production. Other pancreatic problems, including trauma, pancreatitis or
tumors (either malignant or benign), can also lead to loss of insulin production. The
exact cause(s) of type 1 diabetes are not yet fully understood, and research on those
mentioned, and others, continues. In December 2006, researchers from Toronto Hospital
25

for Sick Children published research that shows a link between type 1 diabetes and the
immune and nervous system.

Using mice, the researchers discovered that a control circuit exists between insulinproducing cells and their associated sensory (pain-related) nerves. It's being suggested
that faulty nerves in the pancreas could be a cause of type 1 diabetes. control circuit
exists between insulin-producing cells and their associated sensory (pain-related) nerves.
It's being suggested that faulty nerves in the pancreas could be a cause of type 1 diabetes.
Inhe ritance
Type 1 Diabetes is a polygenic disease, meaning many different genes
contribute to its expression. Depending on locus or combination of loci, it can be
dominant, recessive, or somewhere in between. The strongest gene, IDDM1, is located
in the MHC Class II region on chromosome 6, at staining region 6p21. This is believed
to be responsible for the histocompatibility disorder characteristic of type 1: Insulinproducing pancreas cells (beta cells) display improper antigens to T Cells. This
eventually leads to the production of antibodies that attack these beta cells. Weaker
genes are also located on chromosomes 11 and 18. Environmental factors can strongly
influence expression of type 1. A study showed that for identical twins, when one twin
had type 1 diabetes, the other twin only had type 1 30-50% of the time. Despite having
the exact same genome, one twin had the disease, where the other did not; this shows
that environmental factors, in addition to genetic factors, can influence disease
prevalence.
Treatment
Type 1 is treated with insulin replacement therapy usually by injection
or insulin pump, along with attention to dietary management, typically including
carbohydrate tracking, and careful monitoring of blood glucose levels using Glucose
meters. Today the most common insulins are produced using genetic recombination
techniques; formerly, cattle or pig insulin were used, and even sometimes insulin from
fish. Major suppliers include Eli Lilly and Company, Novo-Nordisk, and SanofiAventis. A more recent trend, from several suppliers, is insulin analogs which are
slightly modified insulin are which have different onset of action times or duration of
action times. Untreated type 1 diabetes commonly leads to coma, often from diabetic
ketoacidosis, which is fatal if untreated. At present, insulin treatment must be continued
for life; this may perhaps change if better treatment, or a cure, becomes clinically
available. Continuous glucose monitors have been developed and marketed which can
alert patients to the presence of dangerously high or low blood sugar levels, but the
general lack of widespread insurance coverage (certainly in the US) and technical
limitations has limited the impact these devices have had on clinical practice so far.
In more extreme cases, a pancreas transplant can restore proper glucose regulation.
26

However, the surgery and accompanying immunosuppression required is considered by


many physicians to be more dangerous than continued insulin replacement therapy, and
is therefore often used only as a last resort (such as when a kidney must also be
transplanted, or in where the patient's blood glucose levels are extremely volatile).
Experimental replacement of beta cells (by transplant or from stem cells) is being
investigated in several research programs and may become clinically available in the
future. Thus far, beta cell replacement has only been performed on patients over age 18,
and with tantalizing successes amidst nearly universal failure.
Pancreas transplantation
Pancreas transplants are generally performed together with or some
time after a kidney transplant. One reason for this is that introducing a new kidney
requires taking immunosuppressive drugs anyway, and this allows the introduction of
a new, functioning pancreas to a patient with diabetes without any additional
immunosuppressive therapy. However, pancreas transplants alone can be wise in
patients with extremely labile type 1 diabetes mellitus.

Islet cell transplantation


Islet cell transplantation is expected to be less invasive than a pancreas
transplant which is currently the most commonly used approach in humans. In one
variant of this procedure, islet cells are injected into the patient liver, where they take up
residence and begin to produce insulin. The liver is expected to be the most reasonable
choice because it is more accessible than the pancreas, and islet cells seem to produce
insulin well in that environment.
The patient's body, however, will treat the new cells just as it would any other
introduction of foreign tissue, unless a method is developed to produce them from the
patient's own stem cells or there is an identify the available who can donate stem cells.
The immune system will attack the cells as it would a bacterial infection or a skin graft.
Thus, patients now also need to undergo treatment involving immunosuppressants, which
reduce immune system activity.
Recent studies have shown that islet cell transplants have progressed to the point that
58% of the patients in one study were insulin independent one year after islet cell
transplant. Ideally, it would be best to use islet cells which will not provoke this
immune reaction, but scientists in New Zealand are also looking into placing the m
within a protective housing derived of sea-weed which enables insulin to flow out and
nutrients to flow in while protecting the islets from immune system attack via white
blood cells.
Prevalence
It is estimated that about 5%10% of North American diabetes patients
27

have type 1. The fraction of type 1 in other parts of the world differs; this is likely due
to both differences in the rate of type 1 and differences in the rate of other types, most
prominently type 2. Most of this difference is not currently understood. Variable criteria
for categorizing diabetes types may play a part.

Cure
As of 2009, there is no known cure for diabetes mellitus type 1 in
modern clinical use. Pancreas transplant is not practical (too few are available, and
pancreas transplant is technically difficult. The requirement for immuno- suppressive
drugs contributes to the unsatisfactory nature of pancreas transplant as a cure). Nor is a
cure known from any other source including traditional or alternative medical practice.
There is ongoing research on various approaches to curing diabetes type 1.
Diabetes type 1 is caused by the destruction of enough beta cells to produce symptoms;
these cells, which are found in the Islets of Langerhans in the pancreas, produce and
secrete insulin, the single hormone responsible for allowing glucose to enter from the
blood into cells (in addition to the hormone amylin, another hormone required for
glucose homeostasis).
Hence, the phrase "curing diabetes type 1" means "causing a maintenance or restoration
of the endogenous ability of the body to produce insulin in response
to the level of blood glucose" and cooperative operation with counter regulatory
hormones.
This section deals only with approaches for curing the underlying
condition of diabetes type 1, by enabling the body to endogenously, in vivo, produce
insulin in response to the level of blood glucose. It does not cover other approaches,
such as, for instance, closed-loop integrated glucometer/insulin pump products, whic h
could potentially increase the quality-of- life for some who have diabetes type 1, and
may by some be termed "artificial pancreas".

28

Reversion
Encapsulation approach

Fig no : 2 Bio-artificial Pancreas sheet technology


The Bio-artificial pancreas: a cross section of bio-engineered tissue
with encapsulated islet cells delivering endocrine hormones in response to glucose.
A biological approach to the artificial pancreas is to implant bioengineered tissue
containing islet cells, which would secrete the amounts of insulin, amylin and
glucagon needed in response to sensed glucose.
When islet cells have been transplanted via the Edmonton protocol,
insulin production (and glycemic control) was restored, but at the expense of
continued immunosuppression drugs. Encapsulation of the islet cells in a protective
coating has been developed to block the immune response to transplanted cells, which
relieves the burden of immunosuppression and benefits the longevity of the transplant.
One concept of the bio-artificial pancreas uses encapsulated islet cells to build an islet
sheet which can be surgically implanted to function as an artificial pancreas.

This islet sheet design consists of an inner mesh of fibers to provide strength for the
islet sheet; islet cells, encapsulated to avoid triggering a proliferating immune
response, adhered to the mesh fibers; a semi-permeable protective layer around the
sheet, to allow the diffusion of nutrients and secreted hormones; a protective coating,
to prevent a foreign body response resulting in a fibrotic reaction which walls off the
sheet and causes failure of the islet cells. Islet sheet with encapsulation research is
pressing forward with large animal studies at the present, with plans for human
clinical trials within a few years.
29

Islet cell regeneration approach:


Research undertaken at the Massachusetts General Hospital between
2001 and 2003 demonstrated a protocol to reverse type 1 diabetes in non-obese
diabetic mice (a frequently used animal model for type 1 diabetes mellitus). Three
other institutions have had similar results, as published in the March 24, 2006 issue of
Science. A fourth study by the National Institutes of Health achieved similar results,
and also sheds light on the biological mechanisms involved.

30

Gene therapy approach

Fig no : 3 DNA Gene therapy using an adenovirus

Gene therapy:
Designing a viral vector to deliberately infect cells with DNA to carry on
the viral production of insulin in response to the blood sugar level. Technology for gene
therapy is advancing rapidly such that there are multiple pathways possible to support
endocrine function, with potential to practically cure diabetes. Gene therapy can be used
to manufacture insulin directly: an oral medication, consisting of viral vectors
containing the insulin sequence, is digested and delivers its genes to the upper
intestines. Those intestinal cells will then behave like any viral infected cell, and will
reproduce the insulin protein. The virus can be controlled to infect only the cells which
respond to the presence of glucose, such that insulin is produced only in the presence of
high glucose levels. Due to the limited numbers of vectors delivered, very few
intestinal cells would actually be impacted and would die off naturally in a few
days. Therefore by varying the amount of oral medication used, the amount of insulin
created by gene therapy can be increased or decreased as needed. As the insulin
producing intestinal cells die off, they are boosted by additional oral medications.
31

Gene therapy might eventually be used to cure the cause of beta cell destruction,
thereby curing the new diabetes patient before the beta cell destruction is complete and
irreversible.
Gene therapy can be used to turn duodenum cells and duodenum adult
stem cells into beta cells which produce insulin and amylin naturally. By delivering beta
cell DNA to the intestine cells in the duodenum, a few intestine cells will turn into beta
cells and subsequently adult stem cells will develop into beta cells. This makes the
supply of beta cellsin the duodenum self replenishing, and the beta cells will produce
insulin in proportional response to carbohydrates consumed.

32

Prevention:
"Immunization" approach:
If a biochemical mechanism can be found that prevents the immune
system from attacking beta cells, it may be administered to prevent commencement of
diabetes type 1. Several groups are trying to achieve this by causing the activation
state of the immune system to change from Th1 state (attack by killer T Cells) to
Th2 state (development of new antibodies). This Th1-Th2 shift occurs via a change in
the type of cytokine signaling molecules being released by regulatory T-cells. Instead
of pro- inflammatory cytokines, the regulatory T-cells begin to release cytokines that
inhibit inflammation. This phenomenon is commonly known as "acquired immune
tolerance".

2) Type 2 diabetes:
Diabetes mellitus type 2 or type 2 diabetes (formerly called noninsulindependent diabetes mellitus (NIDDM), or adult-onset diabetes) is a metabolic disorder
that is characterized by high blood glucose in the context of insulin resistance and
relative insulin deficiency. While it is often initially managed by increasing exercise
and dietary modification, medications are typically needed as the disorder progresses.
There are an estimated 23.6 million people in the U.S. (7.8% of the population) with
diabetes with 17.9 million being diagnosed, 90% of whom are type 2. With prevalence
rates doubling between 1990 and 2005, CDC has characterized the increase as an
epidemic. Traditionally considered a disorder of adults, type 2 diabetes is increasingly
diagnosed in children in parallel to rising obesity rates.
Unlike type 1 diabetes, there is little tendency toward ketoacidosis in type 2 diabetes,
though it is not unknown. One effect that can occur is nonketonic hyperglycemia which
also is quite dangerous, though it must be treated very differently. Complex and
multifactorial metabolic changes very often lead to damage and function impairment of
many organs, most importantly the cardiovascular system in both types. This leads to
substantially increased morbidity and mortality in both type 1 and type 2 patients, but
the two haven quite different origins and treatments despite the similarity in
complication
Pathophysiology:

Insulin resistance means that body cells do not respond appropriately


when insulin is present. Unlike type 1 diabetes mellitus, the insulin resistance is
generally "post-receptor", meaning it is a problem with the cells that respond to insulin
rather than a problem with production of insulin.
Other important contributing factors:increased hepatic glucose production (e.g., from
glycogen degradation), especially at inappropriate times (typical cause is deranged
33

insulin levels, as insulin controls this function in liver cells) decreased insulin- mediated
glucose transport in (primarily) muscle and adipose tissues (receptor and post-receptor
defects) impaired beta-cell functionloss of early phase of insulin release in response
to hyperglycemic stimuli Cancer survivors who received allogenic Hematopoietic Cell
Transplantation (HCT) are 3.65 times more likely to report type 2 diabetes than their
siblings. Total body irradiation (TBI) is also associated with a higher risk of developing
diabetes.
This is a more complex problem than type 1, but is sometimes easier to treat, especially
in the early years when insulin is often still being produced internally. Type 2 may go
unnoticed for years before diagnosis, since symptoms are typically milder (e.g., no
ketoacidosis, coma, etc) and can be sporadic. However, severe complications can result
from improperly managed type 2 diabetes, including renal failure, blindness, slow
healing wounds (including surgical incisions), and arterial disorder, including coronary
artery disorder. The onset of type 2 has been most common in middle age and later life,
although it is being more frequently seen in adolescents and young adults due to an
increase in screening programs. A type of diabetes called MODY is occasionally also
seen in adolescents, but this is classified as diabetes due to a specific cause and not as
type 2 diabetes.
Diabetes mellitus type 2 is presently of unknown etiology (i.e.,
origin). Diabetes mellitus with a known etiology, such as secondary to other
disorders, known gene defects, trauma or surgery, or the effects of drugs, is more
appropriately called secondary diabetes mellitus or diabetes due to a specific cause.
Examples include diabetes mellitus such as MODY or those caused by
hemochromatosis, pancreatic insufficiencies, or certain types of medications (e.g.
long-term steroid use).
The fraction of type 2 diabetics in other parts of the world varies substantially, almost
certainly for environmental and lifestyle reasons, though these are not known in detail.
Diabetes affects over 150 million people worldwide and this number
is expected to double by 2025. There is also a strong inheritable genetic connection in
type 2 diabetes: having relatives (especially first degree) with type 2 increases risks of
developing type 2 diabetes very substantially. In addition, there is also a mutation to
the Islet Amyloidal Polypeptide gene that results in an earlier onset, more severe, for m
of diabetes. About 55 percent of type 2 are obese chronic obesity leads to increased
insulin resistance that can develop into diabetes, most likely because adipose tissue
(especially that in the abdomen around internal organs) is a (recently identified) source
of several chemical signals to other tissues (hormones and cytokines). Other research
shows that type 2 diabetes causes obesity as an effect of the changes in metabolism
and other deranged cell behavior attendant on insulin resistance. Diabetes mellitus
type 2 is often associated with obesity, hypertension, elevated cholesterol (combined
hyperlipidemia), and with the condition often termed Metabolic syndrome (it is also
known as Syndrome X, Reavan's syndrome, or CHAOS). It is also associated with
34

acromegaly, Cushing's syndrome and a number of other endocrinological disorders.


Additional factors found to increase risk of type 2 diabetes include aging, high- fat
diets and a less active lifestyle.

Diagnosis
The World Health Organization definition of diabetes is for a single
raised glucose reading with symptoms otherwise raised values on two occasions, of
either: fasting plasma glucose 7.0 mmol/l (126 mg/dl)or With a Glucose tolerance
test, two hours after the oral dose a plasma glucose 11.1 mmol/l (200 mg/dl)
Screening and prevention
Prevention
Onset of type 2 diabetes can often be delayed through proper
nutrition and regular exercise. Interest has arisen in preventing diabetes due to
research on the benefits of treating patients before overt diabetes. Although the U.S.
Preventive Services Task Force concluded that "the evidence is insufficient to
recommend for or against routinely screening asymptomatic adults for type 2
diabetes, impaired glucose tolerance, or impaired fasting glucose, this was a grade I
recommendation when published in 2003. However, the USPSTF does recommend
screening for diabetics in adults with hypertension or hyperlipidemia (grade B
recommendation).
In 2005, an evidence report by the Agency for Healthcare Research and
Quality concluded that "there is evidence that combined diet and exercise, as well as
drug therapy (metformin, acarbose), may be effective at preventing progression to DM
in IGT subjects".
Accuracy of tests for early detection

If a 2-hour post loads glucose level of at least 11.1 mmol/L ( 200 mg/dL) is used as
the reference standard, the fasting plasma glucose > 7.0 mmol/L
(126 mg/dL) diagnoses current diabetes with:
sensitivity about 50%
specificity greater than 95%
A random capillary blood glucose > 6.7 mmol/L (120 mg/dL) diagnoses
current diabetes with:
sensitivity = 75%
specificity = 88%
Glycosylated hemoglobin values that are elevated (over 5%), but not in the diabetic
range (not over 7.0%) are predictive of subsequent clinical diabetes in US female
35

health professionals. In this study, 177 of 1061 patients with glycosylated hemoglobin
value less than 6% became diabetic within 5 years compared to 282 of 26281 patients
with a glycosylated hemoglobin value of
6.0% or more. This equates to a glycosylated hemoglobin value of 6.0% or more
having:
sensitivity = 16.7%
specificity = 98.9%

36

Benefit of early detection


Since publication of the USPSTF statement, a randomized controlled
trial of prescribing acarbose to patients with "high- risk population of men and women
between the ages of 40 and 70 years with a body mass index (BMI), calculated as
weight in kilograms divided by the square of height in meters, between 25 and 40.
They were eligible for the study if they had IGT according to the World Health
Organization criteria, plus impaired fasting glucose (a fasting plasma glucose
concentration of between 100 and 140 mg/dL or 5.5 and 7.8 mmol/L) found a number
needed to treat of 44 (over 3.3 years) to prevent a major cardiovascular event. Other
studies have shown that lifestyle changes, xenical and metformin can delay the onset o f
diabetes.

Treatment:
Diabetes mellitus type 2 is a chronic, NON-progressive disorder that
has no established cure, but does have well-established treatments which can delay or
prevent entirely the formerly inevitable consequences of the condition. Often, the
disorder is viewed as progressive since poor management of blood sugar leads to a
myriad of steadily worsening complications. However, if blood sugar is properly
maintained, then the disorder is effectively cured - that is, patients are at no heightened
risk for neuropathy, blindness, or any other high blood sugar complication. There are
two main goals of treatment:
1. reduction of mortality and concomitant morbidity (from assorted diabetic
complications)
2. preservation of quality of life

The first goal can be achieved through close glycemic control (i.e., to
near 'normal' blood glucose levels); the reduction in severity of diabetic side effects has
been very well demonstrated in several large clinical trials and is established beyond
controversy. The second goal is often addressed (in developed countries) by support and
care from teams of diabetic health workers (usually physician, PA, nurse, dietitian or a
certified diabetic educator). Endocrinologists, family practitioners, and general
internists are the physician specialties most likely to treat people with diabetes.
Knowledgeable patient participation is vital to clinical success, and so patient education
is a crucial aspect of this effort. Type 2 is initially treated by adjustments in diet and
exercise, and by weight loss, most especially in obese patients. The amount of weight
loss which improves the clinical picture is sometimes modest (2-5 kg or 4.4-11 lb); this
is almost certainly due to currently poorly understood aspects of fat tissue activity, for
instance chemical signaling. In many cases, such initial efforts can substantially restore
insulin sensitivity. In some cases strict diet can adequately control the glycemic levels.
37

Treatment goals

Treatment goals for type 2 diabetic patients are related to effective


control of blood glucose, blood pressure and lipids to minimize the risk of long-term
consequences associated with diabetes. They are suggested in clinical practice
guidelines released by various national and international diabetes agencies.

The targets are:


HbA1c of 6% to 7.0% Preprandial blood glucose: 4.0 to 6.0 mmol/L (72 to 108 mg/dl)
2-hour postprandial blood glucose: 5.0 to 8.0 mmol/L (90 to 144 mg/dl) In older
patients, clinical practice guidelines by the American Geriatrics Society states "for frail
older adults, persons with life expectancy of less than 5 years, and others in whom the
risks of intensive glycemic control appear to outweigh the benefits, a less stringent
target such as 8% is appropriate".

38

Self monitoring of blood glucose


Self- monitoring of blood glucose may not improve outcomes in some
cases that are among "reasonably well controlled non-insulin treated patients with type
2 diabetes". Nevertheless, it is very strongly recommended for patients in whom it can
assist in maintaining proper glycemic control, and is well worth the cost (sometimes
considerable) if it does. It is the only source of current information on the glycemic
state of the body, as changes are rapid and frequent, depending on food, exercise, and
medication, and secondarily, on time of day, stress, infection, etc.
Self manage ment

Diabetes self- management education is an integral component of


medical care. Among adults with diagnosed diabetes, 12% take both insulin and oral
medications,19% take insulin only, 53% take oral medications only, and 15% do not
take either insulin or oral medications.
Traditionally, information regarding diabetes would be obtained from a family
physician. This information can be beneficial, but care must be taken to ensure the
information is medically sound. Several of the external links below provide
information about diabetes and its management, including self- management.

Ant diabetic drugs:


There are several drugs available for type 2 diabetics -- most are
unsuitable or even dangerous for use by type 1 diabetics. They fall into several
classes and are not equivalent, nor can they be simply substituted one for another. All
are prescription drugs.

Oral drugs:
A systematic review of randomized controlled trials found that
metformin and second-generation sulfonylureas are the preferred choices for most
with type 2 diabetes, especially those early in the course of the disorder. Failure o f
response after a time is not unknown with most of these agents: the initial choice o f
anti-diabetic drug has been compared in a randomized controlled trial which found
"cumulative incidence of monotherapy failure at 5 years to be 15% with rosiglitazone,
21% with metformin, and 34% with glyburide". Of these, rosiglitazone users showed
more weight gain and edema than did non-users.

39

Rosiglitazone may increase risk of death from cardiovascular causes


though the causal connection is unclear. Pioglitazone and rosiglitazone may also
increase the risk of fractures. For patients who also have heart failure, metformin may
be the best tolerated drug.
Injectable peptide analogs
DPP-4 inhibitors lowered A1C by 0.74%, comparable to other ant
diabetic drugs. GLP-1 analogs resulted in weight loss and had more gastrointestinal
side effects, while DPP-4 inhibitors were weight neutral and increased risk for
infection and headache, but both classes appear to present an alternative to other ant
diabetic drugs.
Insulin preparations
If ant diabetic drugs fail (i.e., the clinical benefit stops), insulin
therapy may be necessary usually in addition to oral medication therapy to
maintain normal or near normal glucose levels.
Typical total daily dosage of insulin is 0.6 U/kg. But, of course,
best timing and indeed total amounts depend on diet as well the degree of insulin
resistance. More complicated estimations to guide initial dosage of insulin are:
For men, [(fasting plasma glucose [mmol/liter]5)x2] x (weight
[kg](14.3xheight [m])height [m]) For women, [(fasting plasma glucose [mmol/liter]
5)x2] x (weight [kg](13.2xheight [m])height [m])
The initial insulin regimens are often chosen based on the patient's blood glucose
profile. Initially, adding nightly insulin to patients failing oral medications may be
best. Nightly insulin combines better with metformin than with sulfonylureas. The
initial dose of nightly insulin (measured in IU/d) should be equal to the fasting blood
glucose level (measured in mmol/L). If the fasting glucose is reported in mg/dl,
multiply by 0.05551 to convert to mmol/L.
When nightly insulin is insufficient, choices include :
Premixed insulin with a fixed ratio of short and intermediate acting
insulin; this tends to be more effective than long acting insulin, but is associated with
increased hypoglycemia. Initial total daily dosage of biphasic insulin can be 10 units if
the fasting plasma glucose values are less than 180 mg/dl or 12 units when the fasting
plasma glucose is above 180 mg/dl". A guide to titrating fixed ratio insulin is available.
Long acting insulins such as insulin glargine and insulin detemir. A
meta-analysis of randomized controlled trials by the Cochrane Collaboration found
"only a minor clinical benefit of treatment with long-acting insulin analogues for
patients with diabetes mellitus type 2". More recently, a randomized controlled trial
found that although long acting insulin were less effective, they were associated with
40

reduced hypoglycemic episodes.


Antihypertensive agents
The goal blood pressure is 130/80 which is lower than in non-diabetic patients.

ACE inhibitors
The HOPE study suggests that diabetics should be treated with ACE inhibitors
(specifically ramipril 10 mg/d) if they have one of the following:
Hypertension hypercholesterolemia or reduced low high-density lipoprotein
cholesterol levels cigarette smoking microalbuminuria. After treatment with
ramipril for 5 years the number needed to treat was 50 patients to prevent one
cardiovascular death. Other ACE inhibitors may not be as effective.

Hypolipide mic agents


1) Gastric bypass surge ry
Gastric Bypass procedures are currently considered an elective
procedure with no universally accepted algorithm to decide who should have the
surgery. In the diabetic patient, certain types result in 99-100% prevention of insulin
resistance and 80-90% clinical resolution or remission of type 2 diabetes. In 1991, the
NIH (National Institute of Health) Consensus Development Conference o n
Gastrointestinal Surgery for Obesity proposed that the body mass index (BMI)
threshold to consider surgery should drop from 40 to 35 in the appropriate patient.
A study of 20-years of Greenville gastric bypass patients found that
80% of those with type 2 diabetes before surgery no longer required insulin or oral
agents to maintain normal glucose levels. Weight loss occurred rapidly in many people
in the study who had had the surgery. The 20% who did not respond to bypass surgery
were, typically, those who were older and had diabetes for over 20 years
2) Suspected action mechanis m
The effectiveness of gastric bypass surgery in type 2 remission
was long thought to be due to weight loss. When it was discovered that rats whose
duodenum and upper lower intestine were removed also showed the type 2 remission
effect, and when this was also observed in humans, the suspicion arose that some
signal originating in the excised tissue was responsible for the development or
maintenance of type 2's insulin resistance. When that signal is removed, body cells
revert to normal behavior and lose their insulin insensitivity.
41

3) Gestational Diabetes
Gestational diabetes is a form of diabetes which affects
pregnant women. It is believed that the hormones produced during pregnancy reduce
a woman's receptivity to insulin, leading to high blood sugar levels. Gestational
diabetes affects about 4% of all pregnant women. It is estimated that about 135,000
cases of gestational diabetes arise in the United States each year.
Hormones involved in development of placenta, which helps the
baby to develop also blocks, the action of the mother's insulin in her body. This
problem is called insulin resistance. During pregnancy a mother may need up to
three times more insulin for glucose to leave the blood and transform to energy.
When body is not able to use insulin due to insulin resistance it develops into
Gestational Diabetes. Glucose builds up in the blood to high level, it is called
hyperglycemia. Gestational diabetes affects the mother in late pregnancy and the
baby too. Insulin does not cross the placenta, as glucose and other nutrients do.
Extra blood glucose passes through the placenta that gives the baby a high blood
glucose level. It results the baby's pancreas to make extra insulin to get rid of the
blood glucose. Since the baby is getting more energy than it needs to develop and
grow, the extra energy is stored as fat.
It can lead to Macrosomia i.e. Fat baby. At birth this fat baby develops
problem in breathing or may develop hypoglycemia due to over production of
insulin.

Causes of Diabetes
The precise Etiology of most cases of diabetes is uncertain, although
certain contributing factors are as follows:
Type 1 diabetes
Type 1 Diabetes is autoimmune disorder that affects 0.3% on average. It is result o f
destruction of beta cells due to aggressive nature of cells present in the body.
Researchers believe that some of the Etiology and Risk factors which may trigger
type 1 diabetes may be genetic, poor diet (malnutrition) and environment (virus
affecting pancreas).
Secondly, in most of the cases, diabetes occurs because there is abnormal secretio n
of some hormones in blood which act as antagonists to insulin. Example :
Adrenocortical hormone, Adrenaline hormone and Thyroid hormone.
Type 2 diabetes
Type 2 Diabetes is also called non insulin-dependent diabetes mellitus (NIDDM) or
adult-onset diabetes. It occurs when the body produces enough insulin but cannot
utilize it effectively. This type of diabetes usually develops in middle age. A general
observation says that about 90-95 % of
people suffering with diabetes are type 2; about 80 percent are overweight. It is more
42

common among people who are older; obese; have a family history of diabetes; have
had gestational diabetes. There are number of risk factors found to be responsible for
type 2 diabetes like, the more the Etiology and Risk factors carried by an individual, he
higher the risk for developing diabetes.
Following are the Causes of Diabetes
Hereditary or Inherited Traits :
It is strongly believed that due to some genes which pass from one generation to
another, a person can inherit diabetes. It depends upon closeness of blood relationship as
mother is diabetic, the risk is 2 to 3%, father is diabetic, the risk is more than the
previous case and if both the parents are diabetic, the child has much greater risk for
diabetes.
Age:
Increased age is a factor which gives more possibility than in younger age. This
disorder may occur at any age, but 80% of cases occur after 50 year, incidences
increase with the age factor.
Poor Diet (Malnutrition Related Diabetes) :
Improper nutrition, low protein and fiber intake, high intake of refined products are
the expected reasons for developing diabetes.
Obesity and Fat Distribution:
Being overweight means increased insulin resistance that is if body fat is more than
30%, BMI 25+, waist grith 35 inches in women or 40 inches in males.
Sedentary Lifestyle:
People with sedentary lifestyle are more prone to diabetes, when compared to those
who exercise thrice a week, are at low risk of falling prey to diabetes.

Stress:
Either physical injury or emotional disturbance is frequently blamed as the initial
cause of the disorder. Any disturbance in Cortiosteroid or ACTH therapy may lead
to clinical signs of the disorder.
Drug Induced:
43

Clozapine (Clozaril), olanzapine (Zyprexa),


risperidone (Risperdal),
quetiapine (Seroquel) and ziprasidone (Geodon) are known to induce this
lethal disorder.
Infection:
Some of the strephylococci is suppose to be responsible factor for infection in
pancreas.
Sex :
Diabetes is commonly seen in elderly especially males but, strongly in women and
those females with multiple pregnancy or suffering from (PCOS) Polycystic
Ovarian Syndrome.
Hypertension:
It had been reported in many studies that there is direct relation between high systolic
pressure and diabetes. Serum lipids and lipoproteins: High triglyceride and cholesterol
level in the blood is related to high blood sugars, in some cases it has been studied that
risk is involved even with low HDL levels in circulating blood.
Poverty:
Researchers have uncovered a link between poverty and diabetes. In a survey in the
USA, households with the lowest income- under $15,000- was found to have the
highest incidence of diabetes.
Diabetics Symptoms
In both types of diabetes, signs and symptoms are more likely to be similar
as the blood sugar is high, either due to less or no production of insulin, or insulin
resistance. In any case, if there is inadequate glucose in the cells, it is identifiable
through certain signs and symptoms. These symptoms are quickly relieved once the
Diabetes is treated and also reduce the chances of developing serious health problems.
Diabetes is caused by insufficient insulin entering the bloodstream to
regulate the glucose. It is either caused by cells in the pancreas dying off or receptor
sites clogged up by fat and cholesterol. In some case diabetes is also caused by allergy
reactions of cells in our body. If anybody have the below symptoms, please check with
your family doctor.
44

1. Frequent urination:
If you feel that you are needing to urinate more often than usual or a
compelling urge to urinate, along with discomfort in your bladder.
2. Excessive thirst:
The urge to drink too much beyond a certain limit may be a symptom of high
blood sugar in your bloodstream, and can be an important clue in detecting
diabetes.

3. Increase appetite:
If you are experiencing the drive to eat excessively due to emotional and
physical causes then it is an emotion disorder that compels you to eat even after you
are full. Increased appetite can be an early symptom of diabetes.
4. Unexplained weight loss:
Loss of body weight can occur due to various conditions ranging from eating disorders
to severe metabolic conditions including diabetes. Drastic weight loss of more than 5
to 10 pounds when you're not trying to requires medical attention because it may be a
sign of diabetes.
5. Blurry vision:
This is a symptom of great concern. If the blood sugar levels are too high, sugar builds
up in your eye, this excess sugar also draws in fluid, changing the shape of the lens and
making blurry vision. Certain types of blurry vision can be a medical emergency where
delay can lead to loss of sight.
6. Increased fatigue:
Unlike the tiredness experienced by a healthy person, sudden increase of fatigue
is a bad thing in people with symptoms of diabetes.
Most Type II diabetes is caused by uncontrolled diets that are high in saturated
fat. In the case of the cells of the pancreas dying off, experts believe it is caused
by excessive drinking of alcohol.

45

Diabetic Care
Diabetes can be a tough disorder to handle. There are many reasons for it, firstly,
causes of the disorder are not clearly known, it is difficult to prevent. Secondly, once
you get the disorder, it is not possible to cure the same and
you need to take care of your health for entire life. This task can be quite daunting;
here are a few tips.
Diabetic Care Tips
If you have diabetes, you need to take some precautions, in your day
to day life as well and not only at those times, when you feel sick. Here are some
precautions that you can take in your everyday life:
You should monitor your blood glucose level regularly. Depending on the severity of
your condition, your doctor would tell you about the intervals, in which you should take
the test. You should take regular doses of medicine or insulin, as have been prescribed.
Regular exercise proves to be useful in controlling glucose levels.
However, you should avoid few exercises, that are known to cause further complications
like cardiovascular disorders, hypoglycemia etc. In case your glucose level drops
suddenly during or after exercise, you should consume a fruit juice or some similar
drink that provides you with sugar. Weight reduction is a key of success in managing
diabetes; hence take all the measures of carb control, what you can. In case you are
suffering from any ailment like flu, cold or any other disorder or infection, some extra
precautions need to be taken, to avoid further complications by diabetes:
Check your blood sugar level more frequently, to ensure that no harm is being caused
by diabetes. The illness may force some changes in your diet; consult your
doctor/endocrinologist about the changes you need to make in your diabetes medicine
accordingly.
You should drink lots of water and other clear liquids. Remember not to cut yourself
completely from food even if you are not experiencing hunger. Consult the doctor, if
you feel abnormal in any manner. For example you may be feeling excessively sleepy,
giddy, may have trouble with urination etc.
Even though diabetes is a chronic condition, the same does not mean, that you will
have to avoid every activity you enjoy, once you contract it. You can have the same
amount of fun, provided, that you take certain precautions. Remember, if you have
diabetes, you cannot ignore the precautions, nor do you need to get bogged down
completely by them.

46

Diabetes Care
Eat food at fixed hours
Do not overeat
Do not eat immediately after a workout
Make sure you have three proper meals & light snacks in between
Eat about the same amounts of food each day
Eat your meals and snacks at about the same times each day
Make sure the gaps between your meals are short
Do not eat fast; masticate and munch your food well before you swallow
Drink a lot of water that will help flush the toxins off your system
Avoid fried foods and sweetmeats
Include fresh vegetable salad in every meal
Include sprouts in the diet
Take your medicines at the same times each day
Exercise at about the same times each day
Avoid smoking. Smoking leads to heart disorder and poor circulation Check
your feet for cuts, blisters,
and swelling which are likely to result from diabetes-related nerve damage
Try to stick up to the plan made up for sugar control
Check the other tests such as kidney function, liver function, heart function,
ketone level etc
Check your weight periodically and maintain ideal body weight

Diabetes Diet
Diet plays a significant role in controlling the diabetes. The
diabetic diet may be used alone or else in combination with insulin doses or with
oral hypoglycemic drugs. Main objective of diabetic diet is to maintain ideal
body weight, by providing adequate nutrition along with normal blood sugar
levels in blood. The diet plan for a diabetic is based on height, weight, age, sex,
physical activity and nature of diabetes. While planning diet, the dietician has to
consider complications such as high blood pressure, high cholesterol levels. With
respect to the above factors, a dietician will assess calories to be given, like
scheming the carbohydrates, proteins, fats, type of carbohydrate, amount of fiber
and so on. Exchange meal plan is a diet program which balances the amount of
carbohydrate that we intake per day. Glucose is a sugar released from
carbohydrate so, if we want to control blood sugar we have to limit the
consumption of simple carbohydrate.
47

Carbohydrate foods are given as value per portion, known as the


exchange. This plan helps us to decide on the type of food to be taken, the amount of
food and also the time to eat. You can plan for more flexible meals as you get more
knowledge about the diet for a diabetic, may be like the counting carbohydrate meal
plan or constant carbohydrate. But there is no common diet that works for everyone.
Nor is there any particular diet that works perfectly for any diabetic over a long period.
While planning diabetes diet we should adhere to certain important factors, they are as
follows:
Fiber should be at least 1.4 oz / day Instead of 3 heavy meals, we should go for 4-5 small
mid intervals Replace bakery products and fast foods by simple whole cooked cereals,
and don't eat carbohydrates 2 hours before bedtime Consume fresh fruit and vegetables
at least 5 exchange/ day Diabetics always need to take care of their diet and also about
the food they eat. Care has to be taken because all foods contain not only carbohydrate,
but also some energy value. Protein and fat available in the food are converted to glucose
in the body. This glucose has some effect on the blood sugar level, which has to be taken
care of.
Furthermore, you neednt have to eat only the bland boring diet. Instead, you can eat
more fruits, vegetables and whole grains.
Diabetic Food Pyramid

48

Fats (Limit to 1 serving per meal) a serving can be:10 Peanuts.


1 Tbsp Salad Dresssing
2 Tbsp light salad dressing or saur cream.
1 Tsp margarine, Oil or mayonnaise.
1/8 Avocado.
Sweets (Substitute for starch or fruit serving occasionally) A serving can be:2 Small Cookies.
1 Small Cupcake or Muffin
Cup Ice cream.
1/3 Cup Frozen Yoghurt.
Cup Sherbet.
1 tsp Syrup or Honey.
Milk (2-3 Servings per day) A serving can be:
1 cup Milk.
1 Cup Low Fat.
1 Cup Artificially Sweetened yogurt (No sugar)
Meat / Fish/Chicken (2-3 Serving per day) A serving can be:
2 oz Cooked Lean Meat/Poultry/Fish.
- Cup Tuna or Cottage Cheese.
1 Egg or 4 oz Tofu or 1 oz cheese.
2 Tbsp peanut Butter.
Vegetables (3-5 Serving Per day) A Serving can be:
1 Cup Raw Vegetables.
Cup Cooked Vegetables.
Cup Tomato or Vegetable Juice. Fruits (3
Serving per Day) A Serving Can be:
70 gm small fruit.
Cup canned fruit.
cup Dried Fruit.
Cup Fruit Juice. (No sugar)
Grains, Starchy Vegetables and Beans. (6 plus Servings Per Day) A Serving
Can be:1 Slice of 1 oz bread or (1 oz) Bagel or 5 Crackers or 1 Granola bar.
Hamburger or Hot dog Bun or a tortilla of 6 inch or 2 tacos.
Cup Cooked Cereal, Cooked beans, Lentils, Corn, Peas, S. Potato, Potato
or Pasta.
1 Cup winter Squash, 1 Cup Soup.
1/3 Cup Rice or 3 Cup Plain Popcorn (Fat free)
Avoid the following food items when planning a diabetes diet:
a) Starchy foods such as white bread, pasta and potatoes
49

b) Sugars such as table sugar, honey, fruits and sweets


c) Artificially sweetened juices
d) Fried and processed food
e) Reduce salt intake.
The essential ingredients of a diabetic diet include the following:
a) Carbohydrates
b) Proteins
c) Fibers
d) Saturated fats
Monitoring Diabetes - All about Diabetes
Now that you've been told you have diabetes you'll have to monitor
blood sugar levels and control your glucose level. Your glucose level is based on
the amount of blood sugar in your bloodstream. In basic terms, glucose is found in
the foods we eat, so having a proper diet is obviously a very important part o f
controlling the glucose levels in your bloodstream.
The medical experts agree in saying that your diet and getting regular
exercise are the biggest keys in keeping diabetes under control. Many doctors will
even tell you that diet alone can control Type 2 Diabetes. You will be told what kind
of diet you need to be on based upon your type of diabetes and your body type. You
might want to get a diabetes cook book to get a healthy body and heart. If you have
been diagnosed with Type 1 Diabetes, the best way of controlling it is to test your
glucose levels regularly - as instructed by your doctor - and take the correct level of
medication or insulin.
Since a diabetics body can't produce insulin, as in Type 1 diabetes, or cannot
process the insulin that it does make, which is found in Type 2 diabetes, these blood
sugar levels can vary much more then those of a person in perfect health.
Diabetics afflicted with Type 1 Diabetes should be checking
their blood sugar levels daily before eating. The number of tests each day should a
minimum of 2 times per day, but some patients may need as
many as 6 tests in a day. These tests help determine how much insulin needs to be
taken into the body to help process the glucose. Type 2 diabetics are able to contro l
their diabetes with drugs and dieting However they too need to monitor their blood
sugar levels a few times a week. This should be done immediately after eating a meal
or up to 90 minutes after eating. In addition,
it is a good idea to check your levels before every meal around one day a month
to see exactly how your body interacts with the food that you eat. Are you having
trouble coming up with healthy recipes to cook? You can find a number of diabetes
cook books that are not only healthy for your body, but your heart as well. To check
50

your blood sugar levels, the most commonly used method of obtaining a blood sample
is to prick the finger. You then take the blood that is released and put it onto a testing
strip, which comes with blood sugar level testing kits. This strip is then put into a
measuring device, and processed for around 30 seconds before a result is achieved.
But there is some good news!
Lots of research is on going and a new gadget is now available that checks a diabetics
blood sugar and lets them know if it falls to a dangerous low. Researchers have been
searching for the gadget for years. Monitoring devices are now coming on the market
and by late summer will be available in the United States.
These monitors are not as accurate as "normal" blood tests, finger
lances, but researchers are hoping that within a couple of years it will allow a diabetic
to forgo putting their finger to test for blood glucose levels. If the monitor signals that
blood sugar levels are low, it is necessary to take a blood test for confirmation. The
monitors are also slow to show rapid changes that occur, especially when you
exercise.
This monitor is working to make finger lances outdated for all diabetics. Those
who have used the monitors report little discomfort. A patch worn on the abdomen
may hurt when it goes on because there is a tiny wire placed under the skin to
measure the glucose in cell fluid. Once the patch is on, it is comfortable to wear and
sends information to a receiver. The receiver is about the size of a cell phone.
Researchers are working toward pairing the new monitoring device
to insulin pumps. These pumps have been on the market for years and could reduce
the time needed for controlling diabetes to a minimum. One such product has already
been approved in last year in April and is now offered for sale now.
The monitoring portion of the device will be available until later this summer, so it
isn't fully automatic yet, but it is promising news for those who are trying to contro l
Type 1 or Type 2 diabetes.
Another new treatment going through trials is the delivery of insulin through
inhalation. The insulin is prepared in a dry micro fine powder form which is inhaled
directly into the lungs from where it is absorbed into the blood stream.
Diagnosis
Diabetes is suspected based on symptoms. Urine tests and blood tests
can be used to confirm a diagnose of diabetes based on the amount of glucose in the
urine and blood. Urine tests can also detect ketones and protein in the urine which may
help diagnose diabetes and assess how well the kidneys are functioning. These tests
can also be used to monitor the disorder once the patient is on a standardized diet, oral
51

medications, or insulin.

Brief about Diabetes product


Anti-diabetic drug
Anti-diabetic drugs treat diabetes mellitus by lowering glucose levels
in the blood. With the exceptions of insulin, exenatide, and pramlintide, all are
administered orally and are thus also called oral hypoglycemic agents or oral
antihyperglycemic agents. There are different classes of anti-diabetic drugs, and their
selection depends on the nature of the diabetes, age and situation of the person, as well
as other factors. Diabetes mellitus type 1 is a disorder caused by the lack of insulin.
Insulin must be used in Type I, which must be injected or inhaled. Diabetes mellitus
type 2 is a disorder of insulin resistance by cells. Treatments include (1) agents which
increase the amount of insulin secreted by the pancreas, (2) agents which increase the
sensitivity of target organs to insulin, and (3) agents which decrease the rate at which
glucose is absorbed from the gastrointestinal tract. Several groups of drugs, mostly
given by mouth, are effective in Type II, often in combination. The therapeutic
combination in Type II may include insulin, not necessarily because oral agents have
failed completely, but in search of a desired combination of effects.
The great advantage of injected insulin in Type II is that a well-educated patient can
adjust the dose, or even take additional doses, when blood glucose levels measured by
the patient, usually with a simple meter, as needed by the measured amount of sugar in
the blood.
Insulin
Insulin is usually given subcutaneously, either by injections or by an
insulin pump. Research is underway of other routes of administration. In acute care
settings, insulin may also be given intravenously. There are several types of insulin,
characterized by the rate which they are metabolized by the body.
Secretagogues
Sulfonylureas
Sulfonylureas were the first widely used oral hypoglycemic
medications. They are insulin secretagogues, triggering insulin release by direct action
on the K ATP channel of the pancreatic beta cells. Eight types of these pills have been
marketed in North America, but not all remain available. The "second- generation"
drugs are now more commonly used. They are more effective than first-generation
drugs and have fewer side effects. All may cause weight gain.
Sulfonylureas bind strongly to plasma proteins. Sulfonylureas are only useful in
Type II diabetes, as they work by stimulating endogenous release of insulin. They
work best with patients over 40 years old, who have had diabetes mellitus for under
52

ten years. They can not be used with type I diabetes, or diabetes of pregnancy. They
can be safely used with metformin or -glitazones. The primary side effect is
hypoglycemia.
First- generation agents
o tolbutamide (Orinase)
o acetohexamide (Dymelor)
o tolazamide (Tolinase)
o chlorpropamide (Diabinese)
Second-generation agents
o glipizide (Glucotrol)
o glyburide (Diabeta, Micronase, Glynase)
o glimepiride (Amaryl)
o gliclazide (Diamicron)
Meglitinides
Meglitinides help the pancreas produce insulin and are often called
"short- acting secretagogues." Their mode of action is original, affecting potassium
channels. By closing the potassium channels of the pancreatic beta cells, they open
the calcium channels, hence enhancing insulin secretion.
They are taken with meals to boost the insulin response to each meal.
repaglinide (Prandin) - The maximum dosage is 16 mg/day, taken 0 to
30 minutes before meals. If a meal is skipped, the medication is also skipped.
nateglinide (Starlix) - The maximum dosage is 360 mg/day, usually
120 mg three times a day (TID). It also follows the same
recommendations as repaglinide.
Adverse reactions include weight gain and hypoglycemia.
Sensitizers
Biguanides
Biguanides reduce hepatic glucose output and increase uptake of
glucose by the periphery, including skeletal muscle. Although it must be used with
caution in patients with impaired liver or kidney function, metformin has become the
most commonly used agent for type 2 diabetes in children and teenagers.
Amongst common diabetic drugs, metformin, a biguanide, is the only widely used oral
drug that does not cause weight gain.
metformin (Glucophage). Metformin may be the best choice for patients
who also have heart failure.
phenformin (DBI): used from 1960s through 1980s, withdrawn due to lactic
acidosis risk.
buformin: also withdrawn due to lactic acidosis risk.
53

Metformin should be temporarily discontinued before any radiographic


procedure involving intravenous iodinated contrast as patients are at an increased
risk of lactic acidosis.
Metformin is usually the first-line medication used for treatment of type-2 diabetes.
Initial dosing is 500 mg twice daily, but can be increased up to 1000 mg twice daily.
It is also available in combination with other oral diabetic medications.
Thiazolidinediones
Thiazolidinediones (TZDs), also known as "glitazones," bind to PPAR, a
type of nuclear regulatory proteins involved in transcription of genes regulating
glucose and fat metabolism. These PPARs act on Peroxysome Proliferator Responsive
Elements (PPRE). The PPREs influence insulin sensitive genes, which enhance
production of mRNAs of insulin dependent enzymes. The final result is better use of
glucose by the cells.
rosiglitazone (Avandia)
pioglitazone (Actos)
troglitazone (Rezulin): used in 1990s, withdrawn due to hepatitis and liver
damage risk.
As a result of multiple retrospective studies, there is a concern about rosiglitazone's
safety, although it is established that the group, as a whole, has beneficial effects on
diabetes. The greatest concern is an increase in the number of severe cardiac events in
patients taking it. The ADOPT study showed that initial therapy with drugs of this
type may prevent the progression of disorder, as did the DREAM trial.
In contrast, at least one large prospective study, PROactive 05, has shown
that
pioglitazone may decrease the overall incidence of cardiac events in people with type
II diabetes who have already had a heart attack.

Alpha-glucosidase inhibitors
Alpha- glucosidase inhibitors are "diabetes pills" but not technically
hypoglycemic agents because they do not have a direct effect on insulin secretion or
sensitivity. These agents slow the digestion of starch in the small intestine, so that
glucose from the starch of a meal enters the bloodstream more slowly, and can be
matched more effectively by an impaired insulin response or sensitivity.
These agents are effective by themselves only in the earliest stages of impaired
glucose tolerance, but can be helpful in combination with other agents in type 2
diabetes.
54

miglitol (Glyset)
acarbose (Precose/Glucobay)
These medications are rarely used in the United States because of the severity
of their side effects (flatulence and bloating). They are more commonly
prescribed in Europe. They do have the potential to cause weight loss b y
lowering the amount of sugar metabolized.
Peptide analogs
Overview of insulin secretion
Incretin mimetics
Incretins are insulin secretagogues. The two main candidate molecules that fulfill
criteria for being an incretin are Glucagon- like peptide-1 (GLP-1) and Gastric
inhibitory peptide (aka glucose-dependent Insulinotropic peptide or GIP). Both GLP-1
and GIP are rapidly inactivated by the enzyme dipeptidyl peptidase-4 (DPP-4).

Glucagon-like peptide (GLP) analogs and agonists


GLP agonists bind to a membrane GLP receptor. As a consequence of this, insulin
release from the pancreatic beta cells is increased. Endogenous GLP has a half life of
only a few minutes; thus an analogue of GLP would not be practical.Exenatide (also
Exendin-4, marketed as Byetta) is the first GLP-1 agonist approved for the treatment
of type 2 diabetes. Exenatide is not an analogue of GLP, but rather a GLP agonist.
Exenatide has only 53% homology with GLP, which increases its resistance to
degradation by DPP-4 and extends its half- life.

Liraglutide, a once daily human analogue (97% homology), is being developed by


Novo Nordisk. As of 2007, it is in phase III clinical trials. These agents may also
cause a decrease in gastric motility, responsible for the common side effect of nausea,
and is probably the mechanism by which weight loss occurs.
Gastric inhibitory peptide (GIP) analogs
None are FDA approved
DPP-4 inhibitors
Dipeptidyl peptidase-4 (DPP-4) inhibitors increase blood concentration of the incretin
GLP-1 (glucagon-like peptide-1) by inhibiting its degradation by dipeptidyl peptidase-4
(DPP-4). Examples are:
vildagliptin
sitagliptin

55

Amylin analogues
Amylin agonist analogues slow gastric emptying and suppress
glucagon. They have all the incretins actions except stimulation of insulin secretion. As
of 2007, pramlintide is the only clinically available amylin analogue. Like insulin, it is
administered by subcutaneous injection. The most frequent and severe adverse effect of
pramlintide is nausea, which occurs mostly at the beginning of treatment and gradually
reduces.
Experime ntal agents
Many other potential drugs are currently in investigation by pharmaceutical
companies. Some of these are simply newer members of one of the above classes, but
some work by novel mechanisms. For example, at least one compound that enhances
the sensitivity of glucokinase to rising glucose is in the stage of animal research. Others
are undergoing phase I/II studies.
PPAR/ ligands (muraglitazar and tesaglitazar - development stopped
due to adverse risk profile, aleglitazar - under clinical development) s
SGLT (sodium- dependent glucose transporter 1) inhibitors increase urinary
glucose. FBPase (fructose 1,6-bisphosphatase) inhibitors decrease
gluconeogenesis in the liver.
Herbal extracts
A recent review article presents the profiles of plants with
hypoglycaemic properties, reported in the literature from 1990 to 2000 and states that
"Medical plants play an important role in the management of diabetes mellitus
especially in developing countries where resources are meager."Animal studies have
found that walnut leaf and garlic can significantly reduce fasting blood glucose levels
in rats with alloxan- induced diabetes.
Myrcia
The first registered use of anti-diabetic drugs was as herbal extracts
used by Indians in the Amazon Basin for the treatment of type 2 diabetes, and today
promoted as vegetable insulin although not formally an analog. The major recent
development was done in Brazil around Myrcia sphaerocarpa and other Myrcia
species. "Many countries, especially in the developing world, have a long history of the
use of herbal remedies in diabetes (...) STZ diabetic rats were also used to test Myrcia
Uniflora extracts (...) ". The usual treatment is with concentrated (root) Myrcia extracts,
commercialized in a 4 US dollar per kilogram packed rocks (~100 times cheaper than
equivalent artificial drugs), named "Pedra hume de ka".
Phytochemical analysis of the Myrcia extracts reported kinds of flavanone glucosides
(myrciacitrins) and acetophenone glucosides (myrciaphenones), and inhibitory
56

activities on aldose reductase and alpha-glucosidase.


Cinnamon
At least two studies have shown that cinnamon can act significantly
reducing some effects of diabetes. One study on people used fine ground cinnamo n
(Cinnamomum cassia) for oral consumption. Another study used an extract (MHCP)
on laboratory rats. The study on people published in 2003 conducted in the Department
of Human Nutrition, NWFP Agricultural University, Peshawar, Pakistan concluded
"that the inclusion of cinnamon in the diet of people with type 2 diabetes will reduce
risk factors associated with diabetes and cardiovascular disorders."The study on
laboratory rats at Department of Biochemistry, Biophysics and Molecular Biology,
Iowa State University published in 2001 used purified hydroxychalcone (MHCP) fro m
cinnamon. Part of the study's conclusion stated that "the MHCP is fully capable of
mimicking insulin" and recommended further studies.The Food and Drug
Administration has not yet evaluated the use of cinnamon for the management o f
diabetes.
Ayurvedic Treatment for Diabetes
According to ayurveda, diabetes is a metabolic kapha type of disorder
in which diminished functioning of agni leads to a tendency toward high blood sugar.
(Ayurveda recognizes 24 forms of the disorder commonly classified under Prameha - 4
are due to Vata dosha, 6 are due to Pitta dosha, and 10 are caused by Kapha dosha. The
main causes of these disorders are fat, urine, and Kapha buildups due to foods, liquids,
lifestyle and others.) Ayurvedic practitioners also use several herbal preparations for
diabetics. Exercise is another cornerstone of ayurvedic treatment of diabetes.
1. Juice of bitter melon or bitter gourd (Momordica dioica, Roxb., Karela), or Rose
apple (Eugenia Jambos, Linn., Jambu) or two tender leaves of Bilva (Aegle
Marmelos, Corr., Bael fruit) and Neem (Melia azadirachta, Ravipriya, or Indian Lilac)
may be taken on empty stomach daily.
Juice of Jambu should be taken in an ounce quantity twice daily, and that of Karela in
1-1/2 ounce dose daily.
Shilajit (Swertia Decussata Nimmo.) is another useful medicine (250 mg as a single
dose) should be taken, twice daily with juice of stone apple.
2. Use turmeric. Fill some 00-size capsules with turmeric, and take 2 capsules 3 times
a day, a few minutes before meals. Continue this program for up to a month, and then
reevaluate your condition. Clinical observation suggests that a person who is insulin
dependent will experience a markedly diminished requirement for insulin; the
diabetes can often be brought under control.
3. Take 1/2 teaspoon of ground bay leaf and 1/2 teaspoon turmeric, mixed in
57

1 tablespoon aloe vera gel. Take the mixture twice a day before lunch and dinner.
4. Take twice daily, with powder of rose apple stones (powder of Jambu or Jamun-kiGuthali).
5. Include decoctions of triphala, fenugreek, musta, arjuna, sandalwood, lodhra, ajwan,
gokshura, vidanga, guduchi, haritaki, and chitrak. These may be taken with a small
amount of ghee. Gudmar and shilajit are excellent.
6. Amalaki Churna (500mg), Haldi Powder (Turmeric Powder) 500mg and
Naag Bhasma (125mg) should be taken with honey, twice daily ( A 12- hourly
dose ).
Anti-diabetic spray
Diabetics, who are used to insulin shots, have a painless option a spray which can be delivered through the inner lining of the mouth. And the
pleasure of chewing an insulin bubble gum is not far off for them. Shreya Life
Sciences India, launched the Oral-Recosulin spray in. the product would be the
world's first recombinant DNA human insulin buccal spray effective against Type
I and Type II diabetes. Each pack of Oral- Recosulin will have 80 puffs equivalent
to per unit of injection. Each vial of insulin available in the market now consists
of 300 units of injection priced at a range of Rs 125 to Rs 1,000 but oral Recosulin will come at an approximate price of Rs 2,200 for a pack of two vials.
The drug has been developed by US-based Generex Biotechnology Corporation.
Shreya has entered into a product licensing and distribution agreement with
Generex to market the product in India. The new technology delivers insulin
through Buccal Mucosa directly to the vascular system and, thus, does not enter
the lungs. Hence, there would not be any side effects, Dr Jaime Davidson,
endocrinologist and medical director of Generex, said.
The next non- injectable insulin product of Generex would be 'metcontrol', a chewing
gum, Abajian said.

Yoga
Yogic exercises can help with diabetes. When practiced as part of a
daily yoga routine of breathing exercises, meditation and poses, these exercises
enhance digestion and help the pancreas and liver function more normally,
regulating blood sugar levels.
Yoga Asana Useful for Diabetes:
Sun Salutation
Peacock pose
Locust pose
Leg lift
Chest knee pose
58

Exercise and Diabetes


There are several important benefits of exercise.
Exercise helps reduce blood glucose levels and makes insulin more effective.
Exercise helps people maintain their lower weight.
Exercise is believed to improve insulin's sensitivity (its ability to work).
Exercise reduces the dosage requirement or the need for blood- glucose
medications.
Exercise reduces the risk of cardiovascular disorder.
Many physiotherapists recommend that exercise daily whether you are suffering
from diabetes or not. It will help prevent the disorder or delay the onset if you don't
have diabetes yet. Exercise alone can't control blood-sugar levels, except in rare
cases. Some people have the mistaken notion that as long as they are exercising
vigorously and regularly, they can eat as much of anything they want. This just isn't
true. Exercise won't control blood glucose, although it does influence it. A sound
meal plan forms the cornerstone of all treatment for type-II diabetes. Everything
else must build on that sound base.

59

All about Insulin


The failure to make insulin or insufficiency of insulin is termed as
Diabetes mellitus. Insulin is a natural hormone which controls the level of the sugar
glucose in the blood. Insulin allows cells to use glucose for energy. Cells cannot
utilize glucose without insulin. Excess glucose builds up in the bloodstream,
increasing the risk of diabetes. Glucose is the body's primary source of fuel. Insulin
enables the body cells to take glucose from the bloodstream. The cells might use
glucose for production of energy if required, or it is sent to the liver to preserve it, in
the form of glycogen.
Functions of Insulin
In addition to its role of regulating glucose metabolism, insulin also
Stimulates lipogenesis
Diminishes lipolysis
Increases amino acid transport into cells
Modulates transcription
Altering the cell content of numerous mRNAs
Stimulates growth
DNA synthesis Cell
replication

Structure of Ins ulin


Insulin is composed of 2 peptide chains i.e. A chain and B
chain. Both the chains are linked together by two disulfide bonds, and one disulfide
is formed within the A chain. In most species, the A chain consists of 21 amino
acids and the B chain of 30 amino acids that means it is composed of 51 amino
acids in two peptide chains (A and B). The three-dimensional structure of insulin
molecule (insulin monomer) exists in two main conformations. These differ in the
extent of helix in the B chain due to phenol or its derivatives.

60

Insulin Synthesis
Insulin is synthesized as a preprohormone in the beta cells of the islets of
Langerhans. Its signal peptide is removed in the cisternae of the endoplasmic reticulum
and then packaged into secretory vesicles in the Golgi. It is folded in its native
structure and locked in this conformation by, the formation of 2 disulfide bonds.
Insulin resistance
Insulin resistance comes in picture when the total amount of insulin
produced by the body (pancreas), proves to be insufficient to maintain normal blood
glucose level. Extra insulin may need to break down glucose in order to release
energy. In about 1/3 of the cases blood cells resist to even high level of insulin.
Insulin resistance is mostly associated with high Triglycerides and low HDL,
hypertension, cardiovascular disorder and other such abnormalities. It is in these
abnormalities that we find the insulin resistance syndrome. Few people sometimes
suffer from various symptoms and conditions. It is thus believed that diabetes and
other problems go hand in hand.

Types of Insulin
There are more than 20 types of insulin products available in four
basic forms, each with a different time of onset and duration of action. The decision
as to which insulin to choose is based on an individual's lifestyle, blood sugar level
and a physician's preference and experience. Criterions to be considered in choosing
insulin are:
Onset:- how soon it starts working. Peak
time:- when it works the hardest. Duration:how long it lasts in the body.
Insulin Regimens
Insulin regimen is the way that your insulin injections are organized
throughout the day. Type1 diabetics need more than one injection per day and use
more than one type of insulin. The combination of insulins and the number of times
you take your injections, frame your insulin regimen. There are numerous types of
insulin regimens. Ideally, you will develop an individualized regimen that fits in with
your life style.
Diabetes Insulin Classification
There are five different types of insulins ranging from short to
long acting. Some insulins are clear in appearance, while others are cloudy. Diabetics
61

need varying amounts of both short and long acting insulin as everyone is different
and will respond differently to the insulin they take. Lets see the classification of
different types of insulin.

Rapid onsetfast acting insulin: It is fast acting so starts working within one to 20
minutes. It is clear in appearance and its peak time is about one hour later and lasts for
three to five hours. When you inject rapid onset-fast acting type of insulin, you must
eat immediately after you inject. The two rapid onset-fast acting insulin types currently
available are:
Novo Rapid (Insulin Aspart)
Humalog (Lispro)
Short acting insulin: It looks clear and begins to lower blood glucose levels within 30
minutes, so you need to take your injection half an hour before eating. Short acting
insulin has peak effect of four hours and works for about six hours. Short acting insulin
types, currently available include:
Actrapid
Humulin
Hypurin Neutral (bovine - highly purified beef insulin)
Inte rmediate acting insulin:- Intermediate acting insulin looks cloudy. They have
either protamine or zinc added to delay their action. This insulin
starts to show its effect about 90 minutes after you inject, peak at 4 to 12 hours and
lasts for 16 to 24hours.
Intermediate acting insulins presently available with protamine:
Protaphane
Humulin NPH
Hypurin Isophane (bovine)
Mixed insulin: Mixed insulin is cloudy in appearance. It is a combination of either a
rapid onset- fast acting or a short acting insulin and intermediate acting insulin.
Advantage of it is that, two types of insulin can be given in one injection. When it
shows 30/70 then it means 30% of short acting is mixed with 70%of intermediate
acting insulin.
The mixed insulins currently available include:
NovoMix30
Humalog Mix 25
Mixtard 30/70
Mixtard 20/80

62

Long acting insulin: There are two kinds of long acting insulin available in market,
both with clear appearance.
Lantus (Glargine) - It has no peak period as it works constantly when released
into your bloodstream at a relatively constant rate. (full 24 hours)
Levemir (Detemir) - It has a relatively flat action, can last up to 24
hours and may be given once or twice during the day.
Diabetes Prevention
Prevention is proven to be one of the most effective and powerful
methods to fight diabetes. More than 50% of diabetes is caused due to inappropriate
lifestyle. Regulating lifestyle can prove to be advantageous in downfall of probability
of contracting diabetes in ones life. Loss of weight not only helps in fitness but also
in control of blood sugar levels. Losing 10% of initial body weight and regular
exercise can immensely reduce the risk of diabetes. Physical activities play a key role
in reducing the body weight and on the other also the extra blood sugar is broken
down. It also helps to uphold the blood sugar in the normal range. You are more
liable to diabetes if you are overweight (may also lead to obesity), are having genetic
or hierarchal means of predisposition along with proper physical activity.
Food choices: Foodstuffs containing low glycemic carbohydrates, proteins or fats can
initially help to lose body weight and maintain dancing blood sugar level. Prefer
healthy foods which are low in fats and calories such as lean fish, lean chicken, turkey
and fruits and vegetables. Go slow on fast and fried foodstuffs for prevention of
diabetes. Avoid processed carbohydrates as much as possible. Try to increase highprotein food in your diet. And reduce eating refined flour i.e. white flour, bleached
flour, treated flour and other kind of white flour.
The Fundamentals to prevent diabetes: Diabetes can be prevented by good production
of the insulin and keeping the body fat percent low. Insulin and fats helps to maintain
body weight and control sugar level. Consumption of meals to a small fraction instead
of heavy food also helps to control diabetes. Also avoid eating carbohydrates few
hours before you go to sleep. Taking in high-protein breakfast and 5 or 6 small meals
a day also helps you to maintain the body weight. This will also help to control excess
consumption of fats and carbohydrates.

Diabetes Complications:Once we have crossed the reversible stage of prediabetes and enter
diabetes stage, certain changes start developing in our body. These changes occur due
to high blood sugar level with instability in the hormones as well as blood vessels and
nerves. When these changes become permanent in the body it develops into serious
Diabetes Complications and body indicates these changes by steady symptoms.

63

Symptoms of the Diabetes Complications


Diabetic retinopathy shows symptoms of pain in the eyes and may even
result in loss of vision.
Renal (kidney) disorder shows symptoms of swelling (edema) in the feet
and legs. It then passes over total body and as the disorder progresses, blood
pressure also increases.
Tingling, burning, numbness, tightness, shooting or stabbing pain in the
hands, feet or other parts of your body, especially at night. Digestive
problems also occur if, the nerves controlling internal organs get damaged
(autonomic neuropathy).
You may have scanty or profuse sweating, difficulty of sensing when your
bladder is full, when there is a low blood sugar, increased sexual problems,
weakness, dizziness, and fainting.
Chest pain (angina) or shortness of breath dizziness or light headache, shoulder
or stomach pain, fast heartbeat. You might not show any symptoms until
having a heart attack or stroke.
When alarming symptoms given by the body are ignored and the same status is
maintained, it starts damaging body organs, such as heart, kidney, eye, feet, and skin.
The physiology for each and every affected organ is explained one by one.

Diabetes Treatment and Insulin Proble ms


There are many things which can affect how the insulin is absorbed from the
injection site into the bloodstream.
It includes:
Mode of administration
Selecting the 'right' dose and timing
Selecting a suitable insulin preparation (typically on 'speed of onset and
duration of action' grounds)
Adjusting dosage and timing to fit food intake timing, amounts, and types
Adjusting dosage and timing in accordance with exercise undertaken
Adjusting dosage, type and timing according to other conditions like stress,
illness etc
The dosage is non-physiological in that a subcutaneous bolus dose of insulin
alone is administered instead of combination of insulin
It is dangerous in case of mistake (Hypoglycemia or Hyperglycemia) Once
open insulin may be preserved for 30 days at temperature less
than 86 F.
Diabetes Control
64

Whether your treatment consists of diet alone, diet and tablets or


diet and insulin, you need regular blood tests to keep a check on your blood sugar.
Urine sugar test is not a reliable indicator of diabetes control. When blood glucose
remains higher than 200mg/dl for 8-10 weeks, the concentration of glycosylated
hemoglobin (HbA1c) arises. A (HbA1c) measurement therefore reflects the blood
glucose control over a preceding 2- 3 months period, while the estimates of blood
glucose indicate the glucose value at the time of blood test. HbA1c values between
6-7% indicate very good control on diabetes. You should aim at keeping your blood
glucose in the normal range i.e. between 90-130 mg/dl while fasting and less than
180 mg/dl after meals and HbA1c around 7%. Frequent tests for blood glucose are
necessary when starting treatment with insulin.
If you are doing capillary blood glucose test using a hand held
glucometer, do not squeeze the finger to bring out a sample after you have picked.
This invariably gives a low glucose value. Ask your diabetes nurse for a
demonstration of capillary blood glucose test. Urine test for sugar is not reliable
indicator of diabetes control. Although spillage of sugar in urine occurs when the
blood glucose exceeds 180 mg/dl in the majority of healthy persons, this is not always
so in a patient with diabetes. Most patients with diabetes of many years acquire an
increase in the renal threshold for glucose (capacity to prevent spillage of glucose into
urine). Hence urine test for glucose is not helpful for assessing control of diabetes. In
the presence of urinary infections, the bacteria eats up the sugar present in urine,
thereby making urine test for sugar unreliable.
Trends and Recent Developments:
WHO projects that diabetes death will increase by more than 50% in
the next 10 years without urgent action. Most notably, diabetes-associated deaths
are projected to increase by over 80% in upper-middle income countries between
2006 and 2015. The global diabetes market is projected to have several crucial
product launches by 2011 including Pfizers inhaled- insulin Exubera, with
forecasted sales of over US $2 billion in 2011. Further upcoming classes of
OADs (oral ant diabetics) are also anticipated to push up sales, such as DPP-IV
inhibitors and GLP-1 agonists, making it possible for pharmaceutical companies
to extend their revenue streams. There are also three key new OAD classes.
PPAR agonists, GLP-1 agonists/DPP IV inhibitors, and amlinomimetic agents.
Sales are also forecast to be high for GLP-1 agonist Exenatide LAR and the
DPP-IV inhibitor Galvus at $2.9B and $1.3B, respectively. Inhaled insulin is
expected to play an important role in expanding the insulin market. However,
their success will depend on whether they deliver their promise of increased
convenience and compliance.

65

Indian Pharma Industry Scenario


Global Pharmaceutical Industry grew by 7% to $680 billion in 200708. Branded prescription drugs had the largest share of the market i.e. in 2007 it was
worth $525.1 billion. The second largest segment, generic prescription drugs, was worth
$78.5 billion in 2007 whereas the OTC segment was worth over $90.0 billion in 2007.
Breakup of global pharma market ($ bn)
Branded prescription drug to contribute ~76% of the global pharma
market. India, amongst the fastest growing pharma market. Formulations, to grow at a
robust CAGR going forward OTC 90, Branded prescription 525.5, Generic prescription
78.5 Indias pharmaceutical industry plays a vital role in the healthcare area of the
nation. With the implementation of product patent from the year 2005, there was a
tough Competition for the global market share. Pharmaceutical companies have to
focus more intensively on R&D activity to survive the competition. The Indian pharma
industry ranks Fourth in volume terms and thirteenth in value terms worldwide. The
countries Pharmaceutical market is at US$ 6 billion and is expected to cross US$ 20
billion mark in 2015.
Formulations
Formulations are the end product, which uses bulk drugs. The Indian
formulations Segment has grown at a CAGR of 13.44 percent from 2002- 2007
and is expected to grow at a CAGR of 12.95 percent over 2007-2011.

66

Domestic Formulation Market


Therapeutic

Sales (Crores)

March 2008

% of sales

Category
Ant diabetic

1600

value growth
27.2

6%

Anti- infective

5730

15.2

20%

Cardiac

3480

23.4

12%

Derma

1750

12.6

6%

Gastrointestinal

3500

14.1

13%

Gynaec

1810

18.9

6%

Neuro

1760

16.6

6%

Pain

2840

8.2

10%

Respiratory

2880

11.6

10%

Vitamins

2630

9.8

9%

Total

27980

14.8

100%

Lifestyle segment
Lifestyle segment which includes anti-diabetic, cardiac and gastrointestinal have registered a growth of more than 20% during the year. The total
lifestyle segment contributed to around 31% in the therapeutic category as on March
2008. In 2015, the anti-diabetic market in India is expected to grow at a CAGR of
17.02% to Rs.84 billion and the cardiac market is expected to grow at 12.40% to
Rs.143 billion in sales. India has the worlds largest diabetic population, constituting
20 percent of the worlds diabetic population.

Indian Anti-diabetic Market


India, which is home to the largest diabetic population in the
world, has recorded a 17% rise in the anti-diabetic drug segment. The segment
recorded sales of Rs 1,695 crore in the 12 months to August 2008 compared to Rs
1,402 crore in the corresponding period last year, according to ORG IMS data.
The segments contribution to the Indian pharmaceutical market as of
June 2008 was also higher at 5.1% compared to 4.6% in the corresponding period up
to June 2007. With changing consumption patterns and more sedentary lifestyles in
67

India, industry sources expect this to at least double in the coming year. A study by
Decision Resources, a research-based consulting organization, shows that the
prevalence of type 2 diabetes in India is among the highest in the world with more than
28 million cases in 2007. The prevalence of type 2 diabetes is expected to grow more
rapidly in India than in any other nation, climbing to more than 60 million cases by
2017. Type 2 diabetes is the most common form of diabetes. In type 2 diabetes, either
the body does not produce enough insulin or the cells ignore the insulin.
WHOs Burden of Disorder report states that diabetes is going to
grow by 40% in developed countries, but by 170% in developing countries. Apart fro m
this rise, there are so many undiagnosed people, said International Diabetes
Federation vice-president SM Sadikot. A study by Mr Sadikot has shown that by 2030,
the number of rural people suffering from diabetes will equal those in urban areas.
Oral diabetic medication generated revenues of Rs 1,183 crore in the last year while
insulin posted sales of Rs 511 crore, according to an ORG-IMS report. The top players
in this segment include Abbott, USV, Sanofi Aventis, Sun Pharma, Nicholas Piramal
and Wockhardt.
The number of companies looking to enter this therapeutic area is also on
the rise. Lots of companies are looking at entering the chronic
illness space. With a slowing down of acute illnesses in larger cities and towns and
the change in lifestyles, companies who have a presence in anti- infectives are also
entering the anti-diabetic space, said Alok Dalal, analyst with Religare.
Trying to break into the chronic illness segment is easier when compared to CNS
(central nervous system) segment, he added. Piramals shift in focus from acute to
chronic is a case in point. Lots of companies are working on molecules for diabetes
and we should see a new molecule out in a couple of years. As far as MNCs go, GSK
will probably be the leader in launching a molecule.
Decision Resources report forecasts that the Indian type 2
diabetes drug market will double from $504 million in 2007 to more than $1.1
billion by 2012. This potential has not gone unnoticed by the industry and Indian
companies are not the only ones looking at this segment as a lucrative market.
European companies are also looking at entering this segment either through
collaborations or formal dialogue between governments. The UK is the first to have
taken a step in this direction. There are 180 million diabetic people in the world
today and India accounts for 27% of that. We plan on working with different
organizations and countries to combat this, India being one of them, said Ann
Keen, UK under secretary of state for health, at a diabetes conference in Mumbai
last three month before. Sujay Shetty, associate director at PricewaterhouseCoopers,
said, Chronic disorders like diabetes are going to be a big market going forward.
This segments contribution to the overall pharmaceutical market is going to
increase.
68

Market Metrics
Diabetes is estimated to account for 23% of annual pharmacy store
revenues in the U.S. The largest diabetes care market by a wide margin is the United
States, which, at close to $7 billion in 2002, was well over five times larger than
second-ranked Japan. Again, the World Health Organization (WHO) estimates that
almost 180 million people worldwide are afflicted with diabetes. This number is
expected to more than double by 2030. In 2005, an estimated 1.1 million people died
from Type 1 diabetes. Almost 80% of diabetes deaths occurred in low and middleincome countries and almost half of diabetes deaths occurred in people under the age
of 70 years. Women account for 55% of deaths associated with diabetes.

The global market fro a diabetes drug was valued at US $15 billion in
2005. Oral anti-diabetics were the chief class of drugs - $8.19 billion - and showed a
growth rate of 6.3% over 2004. Total sales for insulin products increased by 16.5% to
total global sales of $6.83 billion in 2004.

The insulin class medications dominate the anti-diabetics market, with a


37.5% share of its global sales.
The United States has the dominant share in the global diabetes market,
with 49.6% of 2005 global share in the global diabetes market, with 49.6% of 2005
global sales.
The leading 7 expanding markets of Anti-Diabetic are US, Japan,
France, Germany, Italy, Spain, and UK. These are 7 major markets of globally & the 7
emerging (expanding) Anti-Diabetic markets are India, China, Indonesia, Turkey,
Mexico, Brazil, and Russia.
Medicines Present in Market

69

A List of Oral Diabetes Medicines


Brand and

< works it
Disadvantage s

Drug Category

Generic

Alpha-

Name
Glyset,

glucosidase

Meglitinides

it

Advantages

Blocks the

Lowers

Precose

absorption of
some
carbohydrate s
in the intestine

blood glucose gas, bloating


after
meals, and diarrhea.
does not cause
low blood
glucose

Glucophag

Helps the

Does not

Can't take if

body use it's


own
insulin
better: muscles
use
more
glucose and the
liver
makes
less glucose.

cause
low
blood
glucose, may
help
with
weight
loss and can
improve
blood lipids
(fats).

you
drink
alcohol
excessively.
Can
cause
nausea
and
diarrhea
when started.

Prandin

Reduces

Rapidly

Can cause

blood
glucose

absorbed
the body.

Inhibitors

Biguanides

How>How
works

May cause

by

blood glucose
to get too

70

levels by

Can be used

stimulating
insulin release
form
the
pancreas.

alone
or
with
metformin.

low.

Thiazolidinedio

Actos,

Works to

Cannot

Can cause

Nes

Avandia

decrease
insulin
resistance
and improves
the
muscle's
ability to use
insulin. Does
not make more
insulin.
>

cause blood
glucose to get
too low if it is
the
only
diabetes pill
taken.

liver
problems.
Some birth
control pills
may
not
work.

Sulfonylureas

Diabeta,

Lowers blood

These are

Can cause

Glucotrol

glucose
by 2nd
blood glucose
helping
the generation
to get too
pancreas
drugs
with low.
produce more fewer
side
insulin.
effects tha n
older
sulfonylurea
s.

XL

Amaryl,
Micronase,
Glynase
Generic:
Glyburide,
Glipizide

71

Recombinant Brand Human Insulin Anti-diabetic Drugs Present in Indian Market

Recombinant Brand Human

Company

Year of Launch

Insulin
Huminsulin

Eli Lilly and

1982

Insugen

Company India
Biocon

2004

NovoMix30 and NovoRapid

Novo Nordisk

2003

Recosulin

Shreya Life Sciences

2004

Wosulin

Wockhardt

2003

72

Major Players of Anti-Diabetic In India


Novo Nordisk India (Diabetes care leader)
Novo Nordisk has a 60% market share in the Rs 375-crore domestic
insulin market. Novo Nordisk India is the Indian subsidiary of Novo Nordisk, a
focused healthcare company and a world leader in diabetes care. The company has
the broadest diabetes product portfolio in the industry, including the most advanced
products within the area of insulin delivery systems. Novo Nordisk has a leading
position in areas such as haemostasis management, growth hormone therapy and
hormone replacement therapy. It manufactures and markets pharmaceutical products
and services that make a significant difference to patients, the medical profession and
society.
Novo Nordisk India employs over 600 persons currently. It plans to triple its staff
strength in four years. The company has a 60 percent market share in the Rs 375-crore
domestic insulin market In May 2006; it launched Levemir, a basal insulin analogue
that works on the mechanism of prolonging action. The insulin is delivered to the
patient through a pen like mechanism.
Novo Nordisk India's FlexPen is priced at Rs 930 for a 300 ml pen, on
par with other analogues in the market. Novo Nordisk India has increased its sales
force that covers 30,000 doctors manning diabetic clinics in India to recommend the
use of Levemir. It imports Levemir from Denmark. The company expects to capture
one- fourth of India's basal insulin market this year. Novo Nordisk India has an
exclusive agreement with Torrent Pharma for the manufacture of insulin formulations.
Torrent Pharma has been manufacturing insulin for Novo Nordisk's India requirement
for more than 15 years now. Besides marketing a portfolio of therapeutics products
like NovoPen 3, Novolet and Flexpen, it has in its basket products like NovoMix 30
(premixed insulin analogue) and NovoRapid (rapid acting insulin analogue). It has a
distributorship alliance with Abbot India. A recent study has shown Novo Nordisk's
FlexPen's superiority over SoloStar, from Sanofi-Aventis. FlexPen is more accurate
when delivering insulin than other pens like the newly launched prefilled device,
SoloStar, from Sanofi- Aventis, which FlexPen significantly outperformed in both
studies, according to a Novo Nordisk company release. The two studies were lead by
Prof Andreas Pftzner from IKFE, Institute for Clinical Research and Development in
Germany,and Dr Toshinari Asakura from the Niigata University of Pharmacy and
Applied Life Sciences in Japan. The German study was published in the May 2008
issue of Diabetes Science and Technology.
General Information
Headquarter:
Denmark
International:
International Production facilities in six Countries. Affiliates or
offices in 81 countries. Workforce: More than 27,068 employees (December 2008).
Approximately 48% of employees are located in Denmark (13,050) and 52% in the rest
of the
73

World (North America: 3,727, Japan & Oceania:


1,033, International Operations: 5,587
Europe: 3,671).
17% within research and development
30% in production and production
34% in international sales and marketing
19% in administration
Product areas :
Growth hormone therapy :
Sales :

Diabetes care
Haemostasis management (NovoSeven
Hormone replacement therapy (HRT)
45,5

74

Eli Lilly
Eli Lilly launched Byetta, a new class of drug for Type B diabetics
and has plans to launch new products in the coming years.
Eli Lilly and Company (India) is a 100 percent subsidiary of the US pharmaceutical
major, Eli Lilly and Company. The company first came to India in 1993 as a JV with
Ranbaxy. It became a wholly owned subsidiary in 2001 when Lilly bought the 50
percent stake held by Ranbaxy and since then the company has established a
formidable presence in cardiology, diabetes and oncology amongst other therapeutic
segments. Lilly India has five products from the biotechnology stable. All injectibles,
they are human insulin (including human insulin analogs), human growth hormone,
Teriparatide (Forteo), Drotrecogin Alfa (Xigris) and Exenatide (Byetta). Overall,
diabetes care product range contributes roughly 60 percent of the Lilly India revenue.
In the biotech category, the company grew an impressive 20 percent in 2007 clocking
revenue of Rs 137 crore compared to Rs 114 crore in 2006. The company's recent
product launches include Byetta that was introduced in October 2007. The drug
belongs to a new category called "incretin mimetics" and is a unique treatment option
for Type 2 diabetics, more specifically for patients who have maxed out on the OHA's
(oral hypoglycemic agents). According to Sandeep Gupta, CMD, Lilly, "Byetta is a
first-in-class product. These are early days; however within 3-4 months from its
launch, nearly 1000 patients have been put on the therapy across India." Forteo, Lilly's
novel therapy that 'rebuilds' bones and is used for treating women with osteoporosis,
registered a whopping growth of almost 100 percent in 2007 as compared to the
previous year.
Lilly India recently tied up with an Ahmedabad-based Contract Sales
Organization (CSO), PharmaLink, to further enhance its reach in large towns while
maintaining adequate coverage in smaller markets. The company also divested its
premium antibiotic brand, Distaclor. This was done with a view to augment company
focus on its range of new products. Also in a global deal, the company entered into a
unique drug development agreement with Mumbai-based Nicholas Piramal India Ltd
(NPIL) in 2007. Under this partnership, Lilly has outlicensed a molecule for 'metabolic
disorder' o NPIL with an arrangement to do research till phase III and if the product is
found to show the desired potential.
Wockhardt
Wockhardt is a technology-driven global pharmaceutical and
biotechnology major with an innovative multi-disciplinary research and development
programme. It has 5 research centres and 15 world-class manufacturing plants dotting
various countries and continents that are compliant to international regulatory
standards such as the US FDA, MHRA or other global regulatory bodies. It has endto-end integrated capabilities for its products, starting with manufacture of the oral and
sterile APIs, the dosage forms and marketing through its wholly owned subsidiary in
the US. Wockhardt has a global footprint including the USA, UK, Ireland, France, and
75

Germany with a multi-ethnic workforce from 14 different nationalities A


Pharmaceutical and biotechnology major Wockhardt has announced the launch of its
new insulin (Glaritus), a recombinant long acting human insulin analogue. Wockhardt
is only the 1st company in the world after the innovator to launch this new insulin
(Glaritus) that works slowly for over 24 hours. Currently, the worldwide market for
this insulin (Glargine) is $2 billion. As per ORG IMS, the current market for
analogues in India is Rs. 120 crores growing at 37% per annum. This new insulin
(Glaritus) has been successfully clinically tested on 300 diabetic patients for safety &
efficacy parameters and is approved by the Drug Controller General of India. The
launch of Glaritus is a significant landmark for India, which has one of the highest
diabetes affected populations in the world. The advantage of Glaritus is that it is a
once daily dose and provides basal glucose control over 24 hours. Glaritus can hence
be easily combined with other oral medications of diabetes for effective blood glucose
control. Moreover, Glaritus is meal independent, peakless insulin, which reduces
incidences of hypoglycemia significantly. All this translates into more compliance to
insulin therapy, improved blood glucose control and therefore slower progression of
diabetes related complications. Glaritus is available to the patients as reusable and
disposable pen delivery devices. Wockhardt is one of the few select companies in the
world to patent the technology of pen based insulin delivery devices, which is one of
the most preferred modes of insulin injection across the globe today. Wockhardt
insulin pen devices are ISO 11608 approved and have won the IndiaStar, AsiaStar and
the WorldStar awards for excellence in packaging technology for 2008.

Glaritus is manufactured at Wockhardts state-of-the-art biotech park in Aurangabad.


Wockhardt, over the recent years has built a comprehensive diabetes
management portfolio that includes insulins, oral medications, blood glucose monitors
& diabetes nutrition products.
Aventis Pharma
Aventis has carved a niche for itself in the insulin market. Aventis Pharma
clocked total biotech revenue sales of Rs 105 crore in 2007- 2008 as against the sales of
Rs 119.65 crore in 2006-2007. Targeted therapeutic areas for Aventis Pharma include
oncology, cardiovascular disorder/thrombosis, central nervous system, metabolic
disorders and the prevention and treatment of infectious disorders. It has also been
leading in the anti-rabies vaccines market. It markets anti-rabies vaccines under the
brand Rabipur which figures among the top 100 brands of the retail market. Another
leading brand which contributed to the growth this fiscal was Lantus. The world's first
once daily insulin glargine, Lantus, had an impressive growth of 64 percent in the year.
It is now the fifth largest insulin in India and has a market share of 6.1 percent in its
category. Lantus is expected to register an 80 percent growth in the current fiscal. Also
in a continuous effort in the field of diabetes, a world class Autopen 24 in a starter pack
76

in three cartridges was launched. Amaryl, which is an oral anti- diabetic, had a 4.4
percent share in the oral anti-diabetic market.
Aventis conducted a large observational study in 2007, with around
10,000 patients evaluating effect of the change of the insulin therapy in type 2
diabetes patients whose blood sugar was not under control with the existing insulin
therapy. The study involved 800 doctors. Also another observational study was
implemented with about 200 doctors to observe the management of myocardinal
infarction and usage of anti- thrombotics. Another observation study with Cardace was
implemented in which management of patients who are at high risk of cardiovascular
events in real life settings was evaluated.

Biocon

The total revenues of Biocon, one of India's premier biotechnology


companies, for fiscal 2007-08 increased 19 percent to Rs l,090 crore, up from Rs 990
crore in the previous year, and net profit increased by 3 percent to Rs 225 crore. The
consolidated revenue (excluding enzymes) increased by 19 percent from Rs 881 to Rs
1,044 crore this fiscal. Impressive growth in research services helped Biocon post a
fourth quarter profit of Rs 62.03 crore, a growth of 31.16 percent from Rs 47.29 crore
in the same quarter last year. The company's net sales in the quarter that ended Marc h
31, however, declined 5.92 percent to Rs 219.75 crore and total income fell by 1.09
percent to Rs 236.71 crore.
Biocon's profit growth has been maintained at the consolidated level
despite the divestment of the enzymes business, currency appreciation and increased
depreciation. The company has a strong balance sheet with high reserves and Rs 193
crore in net Established in 1978, Biocon and its two subsidiary companies, Syngene
International and Clinigene International form a fully integrated biotechnology
enterprise, specializing in biopharmaceuticals, custom research and clinical research.
With successful initiatives in clinical development, bioprocessing and global
marketing, Biocon delivers products and solutions to partners and customers across the
globe. Many of these products have USFDA and EMEA acceptance. Biocon launched
the world's first recombinant human insulin, Insugen in November 2004 using Pichia
expression and India's first indigenously produced monoclonal antibody BIOMAbEGFR. Biocon has decided to split up its cardio-diabetes group by launching a standalone cardiology division. This new division is being launched to focus on brand
building for its flagship statin-based product Statix as well as other products viz.
Telmisat, Eptifibatide and its recombinant streptokinase product Myokinase. This
division is envisaged to have an all-India presence through a 250+ strong field force.
77

Shreya Life Sciences


Shreya Life Sciences Pvt Ltd of Mumbai has introduced world's first
buccal insulin spray under the brand name Oral- Recosulin. Shreya Life Sciences has
achieved this major success with the help of US-based Generex Biotechnology
Corporation. The insulin spray will be helpful in treating type-1 and type-2
diabetes patients. Generex Biotechnology has used its special technology to
develop his spray insulin. According to chairman and managing director of Shreya
Life Sciences, Sujit Kumar Singh, each pack of Oral- Recosulin will be available at a
cost of Rs 2200. Oral- Recosulin regulates prandial glucose rapidly within five to 10
minutes of intake. The medicine then last for duration of 120 to 150 minutes. The
major advantage of this insulin spray is that the diabetes patients will no longer
need to take injections. Apart from it, the spray operates very rapidly once consumed
by the patients. According to a company source of Shreya Life Sciences, spra y
insulin will provide simple solution for worldwide diabetes problem Generex
Biotechnology Corporation will market the product in US market under the name o f
Oral-lyn. Under deal, Shreya Life Sciences will provide the insulin crystals while
the buccal device will be supplied by Generex Biotechnology Corporation.
USV LTD.
USV is a leading health care company with the following areas of
focus: Branded Generics, Active Pharmaceutical Ingredients (APIs) and Biosimilar. Sixty-six percent of our business is contributed by the India operations and
the rest by export of APIs and Branded Generics. By Rx (prescription), USV is
rank No. 1 in Diabetes and Cardiovascular disorder segments. USV have an active
in- licensing program to enhance there product portfolio. The strategy is to
introduce innovative specialized products while retaining a focus on brand
building. USV lead the oral anti-diabetic segment in India in terms of value as well
as prescriptions. USV have maintained a leadership position in this segment for
almost two decades. 34% of sales are contributed by the anti-diabetic portfolio,
which includes insulin.
USV lead in the cardiovascular disorder segment in terms of prescription
generation. In terms of value, USV rank amongst the first 10 companies in India.
The cardiology portfolio contributes 30% to our sales.
Presence in Respiratory, Nutritionals, Orthopaedics and Gynaecology segments
is attributed to innovative products through partnerships with companies from
Europe and USA.
USV completed the financial year 2007-08, registering sales of
Rs.7319 million (USD 181 million). USV have a 2759 member work force that have
the opportunity to learn and develop their knowledge in an open, encouraging, team
environment. USV aim at being a reliable healthcare partner to all those they interact
with - whether customer, collaborator, in- license partner, doctor or patient
78

Market Research on Humins ulin-R:Now a days Diabetes is a common disorder in every country.
Thats the reason the anti-diabetic market is expanding or increasing day by day.
Now days Insulin is easily available in every country. Old aged people are suffered
more towards the diabetes. Day by day the number of patient is increasing. To seeing
the opportunity every company launching the anti- diabetic drug.
In India Eli Lilly have major market share in anti-diabetic market. They
have 60% market share, followed the Eli Lilly, Novo Nordisk India is the major
player in India. The major brand of Eli Lilly is Huminsulin (r) U100

Huminsulin-R:How does Huminsulin work? What will it do for me?


Huminsulin- R from Eli Lilly contains Insulin. Insulin is a hormone that is central to
regulating energy and glucose metabolism in the body. Insulin causes cells in the liver,
muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the
liver
and
muscle.
Insulin stops the use of fat as an energy source. When insulin is absent, glucose is not
taken up by body cells and the body begins to use fat as an energy source, for example,
by transfer of lipids from adipose tissue to the liver for mobilization as an energy source.
As its level is a central metabolic control mechanism, its status is also used as a control
signal to other body systems (such as amino acid uptake by body cells). In addition, it
has
several
other
anabolic
effects
throughout
the
body.

79

How should the patient use Huminsulin-R?


Your doctor or diabetes educator will determine the appropriate dose for you
according to various lifestyle factors and the blood glucose values obtained while
monitoring your blood glucose.
Your dose of insulin should be injected subcutaneously (under the skin) exactly
as instructed by your doctor or diabetes educator. Each 1 mL of insulin contains 100
units. Insulin is injected under the skin once or twice daily. In addition to insulin,fastacting insulin is usually used to control the impact of food intake on blood glucose
levels during the day. There are many variations of insulin dosing.
Insulin should be clear and colorless. Do not use the insulin if you notice
anything unusual in the appearance of the solution, such as cloudiness, discoloration,
or clumping. It is not necessary to shake or rotate the vial before use. It should not be
mixed with any other insulin. Many things can affect the dose of a medication that a
person needs, such as body weight, other medical conditions, and other medications.
The timing of insulin with respect to your meals is crucial to keeping blood
glucose under control and preventing unwanted side effects. Do not administer a
double dose to make up for a missed one.
Store unopened bottles of insulin in the refrigerator until needed. They may
be used until the expiry date on the label. Never allow insulin to freeze. Insulin that is
currently in use may be kept at room temperature (below 30C) for no more than 42
days and then discarded. Do not expose insulin to extremely hot temperatures or to
sunlight. Keep insulin out of the reach of children.

Forms of Humins ulin-R


Each mL contains salt-free anhydrous insulin,. Nonmedicinal ingredients:
disodium phosphate dihydrate, glycerol, metacresol, phenol, sodium chloride, zinc
acetate, and Water for Injection. The pH is adjusted by adding aqueous solutions of
hydrochloric acid or sodium hydroxide to approximately 7.4. Insulin is long-acting
that works slowly over about 24 hours. You may have to use insulin in combination
with another type of insulin or with a type of oral diabetes medicine to keep your
blood sugar under control. This medicine is available only with your doctor's
prescription, in the following dosage forms: Parenteral Injection (U.S.) Before
Using This Medicine
For Hminsulin-R, the following should be considere d:
80

Allergies
tell your doctor if you have ever had any unusual or allergic reaction to insulin
detemir. Also tell your doctor and pharmacist if you are allergic to any other
substances, such as foods, preservatives, or dyes.
Pregnancy
the amount of insulin or insulin detemir you need changes during pregnancy. It is
especially important for your health and your baby's health that your blood sugar be
closely controlled before you become pregnant and throughout pregnancy.
Breast-feeding
It is not known whether insulin detemir passes into human breast
milk. Although
most medicines, including human insulin, pass into breast milk in small amounts, many
of them may be used safely while breast-feeding.
Mothers who are taking this medicine and who wish to breast- feed should discuss this
with their doctor.
Children
Studies on this medicine have been done only in adult patients, and there is no specific
information comparing use of insulin in children with use in other age groups.
Older adultsthis medicine has been tested in a limited number of patients
65 years of age or older and has not been shown to cause different side effects or
problems in older people than it does in younger adults.
Other medicines
although certain medicines should not be used together at all, in other cases
two different medicines may be used together even if an
interaction might occur.
Possible Side effects with Huminsulin-R.
Many medications can cause side effects. A side effect is an unwanted
response to a medication when it is taken in normal doses. Side effects can be mild
or severe, temporary or permanent. The side effects listed below are not
experienced by everyone who takes this medication.
The following side effects have been reported by at least 1% of people taking
this medication. Many of these side effects can be managed, and some may go
away on their own over time. redness, itching, or swelling at the site of the
81

injection skin changes at injection site Stop taking the medication and seek
immediate medical attention if any of the following occur: rash or blisters all
over the body seizures symptoms of a serious allergic reaction (i.e., swelling of
face or throat, sudden sweating, vomiting, difficulty breathing, rapid heartbeat,
itchy skin rash, and dizziness) unconsciousness

What other drugs could interact with Huminsulin-R?


There may be an interaction between Huminsulin- R and any of the
following:
If you are taking any of these medications, speak with your doctor or pharmacist.
Depending on your specific circumstances, your doctor may want you to:
stop taking one of the medications,
change one of the medications to another,
change how you are taking one or both of the medications, or
Leave everything as is.
An interaction between two medications does not always mean that you must stop
taking one of them. Speak to your doctor about how any drug interactions are being managed
or should be managed. Medications other than those listed above may interact with this
medication. Tell your doctor or prescriber about all prescription, over-the- counter (nonprescription), and herbal medications you are taking. Also tell them about any supplements
you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the
action of many medications, you should let your prescriber know if you use them.

Huminsulin-R is available as:


10 mL vials (small bottles) for use with a syringe
3 mL PenFill cartridges*
3 mL FlexPen
1 mL InnoLet
* PenFill cartridges are for use with Eli Lilly 3 mL PenFill cartridge compatible
insulin delivery devices and NovoFine disposable needles.
OVERDOSE
Hypoglycemia may occur as a result of an excess of insulin relative to food
intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated
with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed.
More severe episodes with coma, seizure, or neurologic impairment may be treated with
intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent
clinical recovery from hypoglycemia, continued observation and additional carbohydrate
intake may be necessary to avoid reoccurrence of hypoglycemia.
82

DATA ANALYSIS & DATA INTERPRETATION


For the collection of primary data on Huminsuli- R , I take a sample size 50 including
General physician & Diabetalogist . I ask following questions & get following data.
TOPIC: 1
The number of Diabetes patients treated by doctor in one month.

70-80
10%
60-70
7%

20-30
20%

50-60
13%

30-40
23%
40-50
27%

Fig no : 6 The no. of patients approach dr. in a month

The survey was perform on 50 doctors to know how much patients of diabees approach
to doctor in a month. The study showed that patients in the range of 20-30, 30-40,4050,50-60,60-70,70-80 approach were in percentage of 20, 23, 27, 13, 7, 10 respectively.
The communication with doctor during survey concluded that the number of patients
are increasing day by day.one of senior doctor told that initially diabetes was very less
as compared to present. it can be said that the diabetes is increasing in double ratio
specially in old age people.
Few doctors said that the main cause of diabetes is changing life style of the people.
again they gave more focus on city people who are working in night and day shift.

83

TOPIC: 2
The two type of diabetes patients approach to doctors.

0% 0%

IDD
50%

NIDD
50%

Fig no : 7 NIDD and IDD patient

The survey from all doctor concluded that both type of diabetes patient i.e. non- insulin
dependent diabetes mellitus(NDDM) and insulin dependent diabetes mellitus (IDM) approach
to doctor. The approach of both type of diabetes was in near about in equal percentage. But the
communication with doctor in detail provided knowledge that IDDM is more in young people
and they said that the genetic factor is the main reason for this type of diabetes and NDDM
was more in old people and for this they told that the increase in resistance of insulin receptors
with more age.

84

TOPIC: 3
The survey from all doctors concluded that the diabetes is controllable

curable
0%

controllable
100%

Fig no : 8 curable or controllable

After meeting to all doctors it come to known that the diabetes is only controllable i.e. only
management is possible but it can not be cure means no therapy or drug is available which can
permanently make patient free from diabetes. Patients has to regularly monitor glucose level
with glucometer like instruments. Diabetes patient also need to take lot of care in diet and the
medicine should be taken from time to time. The IDDM patient need to take regularly
subcutaneous injection of insulin. the missing of drug dose and carelessness in diet can lead to
threatening condition patient may need to hospitalized.

85

TOPIC: 4
The survey from all doctors about diabetes is a serious disorder-some said yes while
others said no and some come to conclusion that may or may not be.

YES & NO
20%

YES
43%

NO
37%

Fig no :9 Survey of Diabetes whethe r serious disorder

About 43% doctor said that diabetes is a serious disorder .for this they give reason that it is a
chronic illness and not curable, after many years diabetes patient suffers from many other
disorder like diabetic neuropathy, many times in severe case it happens that patient some body
part is need to cut. But about 37% doctors told that it is not a serious disorder. They concluded
that if patient is well educated and has taken lot of care to maintain diabetes he can live a happy
life. the few doctors about 20% said that it can be serious or not depends totally on patient
habit, nature and life style.

86

TOPIC: 5
All doctors said that Herbal drug, Exercise, Yoga help to control diabetes

No
0%

Yes
100%

Fig No:10 Herbal drugs, Exercise, Yoga

The survey with all doctors help to understand that yoga, herbal drug, exercise control diabetes
and provide better health to diabetes patients. The 100% doctors have given positive response.
The regular yoga in morning has given relief to patients. The herbal formulation amla,
cinnamon, bitter gourd, jamun reduce the sugar level. The exercise like jogging etc has also
provided many benefits to patient.

87

TOPIC: 6

The survey from all doctors concluded that nutrition (diet) play important role to
control diabetes.

No
0%

Yes
100%

Fig No: 11 Nutrition helps in controlling Diabetes

Yes, all doctors during survey said that nutrition play important role in control of diabetes.
The proper diet maintain the sugar level at normal level. The patient who has paid lot of
attention on nurtrition needs to take less medication and they also suffers from less side
effects of drug. The diabetic neuropathy, diabetic foot ulcer are very less observed in patient
who has taken care in nutrition.
The doctor also said that the fast food is also responsoible for increasing diabetes patients. So
they advice to take proper calorie food which is needed by patients.

88

TOPIC: 7

The type of drugs used in type-I and type-2 diabetes mellitus.

0%

NIDD
50%

IDD
50%

Fig No: 12 Drugs used

The doctor said that depending on type of diabetes drug therapy also need to give different.
They said that in case of IDD mostly subcutaneous injection of insulin is preffered like insulin
lispro, insulin glargline,protmine zinc insulin. While in case of NIDD doctors like to preffered
drug as well as insulin injection. but the diabetes can be controlled mostly by taking drug
tolbutamide, chlorpropmide, metformin, sitagliptin etc. regularly.

89

TOPIC: 8

The most doctors said that the cost of treatment is affordable to patient is not
sufficient while fe w come to conclusion it may or may not be.

YES

NO

BOTH

Fig no : 13, Cost of treatment- Affordable or Not

The statement made by doctors on whether cost of drug is affordable to patient is very
controversial. Some doctor said that it is affordable due to generic products are available in
market and lot of competitors are their for particular which are reducing the cost of drug.
While few said that the cost is not affordable for many patients and there is still need to
reduce the cost of drug. New drugs which are patented is of very high cost and it is not
affordable for many patients.while few doctors said tha t it is easy to pay the price of
diabetes drug but for many patients it is very difficult.

90

TOIPC: 9

The side-effects of the anti-diabetic drug.

60
50
40
30
20
10
0

yes

no

both

Fig No:14 Side-Effect of anti-diabetic drug

The 60% of doctor spoke that there are many side effects like vitamin deficiency, lactic
acidoisis, metallic taste, dryness of mouth, hypohlycemia.hupoglycemia side effect is very
serious it can put patient life in threatening situation. The near about 25% doctor said that there
is not that much side effect which can be neglected but there is only need to take proper dose
should be given to patiens according to situation. some said there are side effect depend on
patient physiology so few doctor said that side effect can be or not.

91

TOPIC: 10

About awareness of brands Humins ulin-R

100%

90%
80%

70%
60%
50%
40%
30%

20%
10%
0%
Metformin

Levemir

Fig No:15 Awarness of Anti-diabetic Brands

The survey concluded that all doctors know about both brands Huminsulin- R. They said brands
are most commonly prescribed. There is no hesitation in writing these brands. Brand have
given excellent result. The patient to whom this brands are prescribed they have given positive
response.

92

Data Analysis and Interpretation for Che mist Questionnaire

Daily Prescription of Anti-diabetic

Sales
7

19

1 to 5

39

5 to 10
10 to 15
35

15 to 20

Inte rpretation:
Daily prescription rate of of Antidiabetic drugs is more in quantity as a result of this question
reply by the chemist is as antidiabetic prescribe by doctor is at the high rate. Average
prescription rate is 10 to 15 prescription daily.

93

Patients asking for the self prescription of of Antidiabetic

Demand

32

Yes
68

No

Inte rpretation:
As the result come after the chemist response for the self prescribing by the patient is due to
the prescription repeating or the result of antidiabetic thus the data shows that the self
prescription of antidiabetic by the patient himself is much higher than the normal
prescription.

94

Patients purchase the Specific Brand due to

Self Prescription Reason

28

33

Doctors Rx
Low Price
Efficacy
39

Inte rpretation:
Patients purchase the specific brand due to the low price and as per the doctors prescription
and the patient has less perception of efficacy in mind while purchasing of the particular
antidiabetic brand

95

Che mist keeps the stock of specific Antidiabetic Brand due to

Reason
19
42
MR Influence
Direct Adv.
Low Price
39

Profit Earn

Inte rpretation:
Chemists keep stock of specific brand of antidiabetic due to the Medical Representative
influence them about the brand and secondary they kept due to the low price of the brand

96

Che mist are Aware of Huminsulin-R

Awareness
0

Yes
No
100

Inte rpretation:
During the survey the result has come to see that che mist is aware of the Huminsulin-R brand
of antidiabetic and they are well known of the efficacy and result of the Huminsulin- R.

97

If yes then either they have or no stock of Humins ulin-R

Stock
21

Yes
No

79

Inte rpretation:
Most of the chemists are aware of the Huminsulin- R and they keep the stock of HuminsulinR and the amount of chemist which are not keep the stock of the Huminsulin- R due to their
specific reason which they dont want to disclosed during the survey.

98

Huminsulin-R is Sold due to either MR Influence, Low Price or Margin of profit

Reason
13

35
MR Influence
Low Price
52

Margin of Profit

Inte rpretation:
According to the chemist response sales of the Huminsulin-R is due to the low price and
same where Medical Representative Influences and every few has response for the margin of
profit.

99

Che mist are personally prefer Huminsulin-R either Yes or No

Preference

29

Yes
71

No

Inte rpretation:
According to the chemist response for the personal preference of Huminsulin- R has shown
the result as Approximately 80% of chemist are prefer Huminsulin-R personally and use the
Huminsulin- R. whereas remaining percentage of chemist doesnt pre fer it due to their
specific reason but many of the chemist personally prefer Huminsulin- R.

100

CONCLUSION

Now a days Diabetes is a very common disorder in India as well as through out the world.
Every fifth person is suffered by the diabetes disorder. India is an expanding stage in Antidiabetic market. In coming few years India is become the top position for diabetic
patient/Market. Currently US & Japan are the major market for diabetic drug. In India
diabetic care division is growing two digit growth nearly about 20% Growth rate. Antidiabetic segment covers 6% overall Pharma industry.
In India Eli Lilly is a market leader in Anti-diabetic drug having 60% share. Eli
Lilly is also world leader in Anti-diabetic drug. In India Novo Nordisk & Eli Lilly have
82% share in this segment.
From doctors perception about diabetes is not a serious disorder, but it affects
the individuals life. In diabetes there is no place of sweet. Diabetes is not a curable but it
is controllable through some tips. Only anti- diabetic drugs are not controlle the diabetes
with this drug Daily exercise, diet management & Yoga is play an important role to
controlle the diabetes.
The aged (old) people suffer more towards the diabetes disorder. There are lots
of factors responsible for diabetes.

101

LIMITATION OF THE STUDY

Few doctors were reluctant to give proper information and few of them were
unreachable.
The survey is carried out only in Navi Mumbai Dist. And some part of Mumbai. So
the interpretation drawn from the data available may be insufficient to comment on
the launch of the product in other cities of the country.

102

SUGGESTION AND RECOMMENDATION

Summary of Analysis
As we look on to the insulin, it show prolong action to treating diabetes. Insulin is
available in the form of humulinbut this insulin are expensive therefore its market is
just 30% among diabetes drug. in spit of being expensive yet it is demanded in the
market. It show that it is increasing at the rate of 27% in the market. If the
manufacture could make insulin little less than before then insulin could be used by
more and more diabetes patients.
The cheapest drug found in the market is Daonil by Aventis which is at Rs 18 for
10tablets and semi Dao nil for Rs. 9for 10tablets. This daonil tablets were extremely
used in last two decades as the other firm drug come in to the market. Which more
effective but just above the price. As per the information, drug manufactures are
increasing the price which can effect their share mostly. The ant diabetic are available
in the price range from Rs.28 to Rs.135 according to their R&d cost and strength
availability price must be frequently low then the ma rket price.

103

APPENDIX
ANNEXURE-I
LIST OF DOCTORS NAME
S.NO

Doctor Name

Qualification

Category

A L joshi

MD

Cons.Phys

A M Nike

MBBS

Cons.Phys

ABHISAR
KATIYAR

MS ORTHO

Ortho

ABJALPURKAR

MBBS

G.P.

AJAY MEHETA

MD

physician

AL PARMAL

MBBS

G.P.

ALKANANDA DAS

MBBS

physician

AMOD DIVEKAR

MS ORTHO

Ortho

ANIL DONGRE

MD.DPM

Psychiatrists

10

ANIL MEHETA

MBBS

G.P.

11

ANIL SHANKAR

MBBS

G.P.

12

ANIL TALATHI

MBBS

G.P.

13

ARVIND JOSHI

MD

physician
104

14

ARVIND KOTOC

MBBS

G.P.

15

ASHOK BHOIR

MBBS

G.P.

16

ASHOK JADHAV

MD

physician

17

ayati ganhi

md

Cons.Phys

18

B G MEHTA

MBBS

G.P.

19

B. KHEDEKAR

MBBS

G.P.

20

B.G.KAMBLE

MD

physician

21

B.J.SHINDE

MD

physician

22

C.D. KULKARNI

MBBS

G.P.

23

D.A. SHIRODKAR

MD

physician

24

D.V.DIVEKAR

MBBS

G.P.

25

deepak mane

md dpm

Psychiatrists

26

DEEPAK PUROHIT

MS ORTHO

Ortho

27

DEEPAK
WAJEKAR

MBBS

G.P.

28

DEPALI MANE

MBBS

G.P.
105

29

DEVIDAS
GHANATE

MD

physician

30

DILIP JAIN

MBBS

G.P.

31

FAIZAL
DESHMUKH

MD

physician

32

FARAH
NAZAEKAR

MBBS

G.P.

33

G.S.KADAM

MBBS

G.P.

34

G.S.PATIL

MBBS

G.P.

35

HARSHAL
WALINGKAR

MS ORTHO

Ortho

36

HEMANT DALVI

MD

physician

37

j n kolhe

Mbbs

G.P.

38

jagdish bedekar

mbbs,md

physician

39

K C METHA

MBBS

G.P.

40

kaustik seth

Mmbs

G.P.

41

KIRTI SAMUDRA

MD

physician

42

KUMAR SHINDE

MBBS

G.P.

43

L.D.PATIL

MBBS

G.P.

44

M.L. LAD

MD

physician

45

M.M. DOSHI

MBBS

G.P.

106

46

Madhav g bhaware

md

physician

47

MADHURI KALITA

MBBS

Cons.Phys

48

madhusudan joshi

md

G.P.

49

SHAILESH
PAREKH

MD

PHY.

50

GIRISH MOHAARI

MD

PHY.

107

ANNEXURE-II
LIST OF CHEMIST SHOP
S No.

Che mist Shop Name

Shree krishna medical store

Minal medical store

Swami narayan medical store

Rahul medical store

Sukhwani medical store

Kapil medical store

Shweta medical store

M D sukhwani medical store

Shree medicose

10

Vikas medicose

11

Life line medical store

12

Sifa medical store

13

Jay medical store

14

Shree param medical store

15

Punit medical store

16

Subhash medical store

17

Tapti health service private limited

18

Jivan jyoti medical store

19

Medi sales

20

Ashok medical store

21

Happy medical store

22

Roz medical

23

Saikripra medical store

108

24

Pawan medical store

25

Ashish medical store

26

Ruby pharmacy

27

Khandelwal medical store

28

Sahara medical store

29

Priyanka medical store

30

Shreenath medical store

31

Mir pharma

32

Mahendra medical store

33

Yash medical store

34

Atharav medical store

35

Vinus medical store

36

Natraj medical store

37

Pooja pharma

38

Hatmi medical store

39

Sarthak medical store

40

Hariom medical store

109

ANNEXURE-III

Doctors Questionnaire

Name-

Qualification

Age-

Specialty-

Area-

110

Questionnaire:
1. How Many diabetes patient treat in one month ? ______________
2. What type of diabetes patients approach you?
NIDD

IDD

3. Diabetes is curable or controllable ? ______________________


4. Is Diabetes is a serious disorder ?
YES

NO

5. Does Herbal drug, Exercise, Yoga help to control the disorder?


_____________________________________________________________
6. Can Nutrition (diet) play important role to control diabetes?
YES

NO

If yes which type of nutritional supplement do you prefer to your patient ?


__________________________________________________________
7. What drugs do you use in the following cases:
a) Insulin
Dependent
Diabetes
______________________________________________________________
b) Non Insulin Dependent Diabetes
______________________________________________________________
8. Do you fill that the cost of the treatment you prescribe is affordable to patient?
YES

NO

9. Have you seen any side effects of the anti diabetic drug you prescribe?
YES

NO

If
yes,
____________________________________________________________

what

10. Are you aware of brands Huminsulin- R?


Huminsulin- R
YES
NO
11. Can you describe the advantages of the Huminsulin-R
____________________________________________________________

111

ANNEXURE-IV
QUESTIONNAIRES

Che mist Questionnaire

Shop Name-

Area-

Nearby Doctor-

112

1. What is the Daily Prescription of Antidiabetic?


a) 1-5
b) 5-10
c) 10-15
d) 15-20

2. Is Patients asking for the self prescription of Antidiabetic?


a) Yes
b) No

3. Patients purchase the Specific Brand due to


a) Doctors prescription
b) Low Price
c) Efficacy

4. You keep the stock of specific Antidiabetic Brand due to


a) Influence of MR
b) Direct Advertisements
c) Low Price
d) Profit Earn

5. Are you aware of Huminsuli-R?


a) Yes
b) No

6. If yes then do you have stock of Huminsuli-R?


a) Yes
b) No

7.
8. Huminsuli-R is Sold due to
a) MR Influence
b) Low Price
c) Margin of profit

9. Do you pe rsonally prefer Huminsuli-R?


a) Yes
b) No
113

ANNEXURE-V
REFERENCES
BOOKS REVIEW:
a) Michael Wilson, Rod McNab, Brian Henderson
Bacterial Disease Mechanisms - An Introduction to Cellular Microbiology
Cambridge University Press April 2002
b) Edited by Charles J Dutton, Mark A Haxell, Hamish A. I. McArthur and Richard
G. Wax
ANTIDIABETIC - Discovery, Modes of Action, and Applications
Marcel Dekker December 2001
c) Edited by Wilson & Gisvold's
Wilson & Gisvold's Textbook of Organic Medicinal and Pharmaceutical Chemistry
11th Ed.
Oregon State University, Corvallis.
d) Edited by K Kumme rer
Pharmaceuticals in the Environment - Sources, Fate, Effects and Risks - 3rd
Edition
Springer 2008
e) Alan Nathan
Non-Prescription Medicines 2nd Edition
f) Stuart Hogg
Essential Microbiology
Wiley June 2005
g) Research Methodology
By Uma Shekharan
Websites
www.wikipedia.com
www.diabeticindia.com
www.diabeticinformationhub.com
www.cygnusindia.com
www.herbalgram.org
www.marketresearch.com
www.diabetescare.com www.thehindu.com

114

Potrebbero piacerti anche