Gla-300 for the Management of Insulin-treated

Patients with Diabetes

Usability of the Gla-300 SoloSTAR® pen

Aimee Andag-Silva, MD, FPCP, FPSEDM
Chief, Section of Endocrinology, Diabetes & Metabolism
Asst. Professor, De La Salle College of Medicine
De La Salle University Medical Center
Cavite, Philippines
 Redesigned features of the Gla-300 SoloSTAR® pen

• Certain features of the SoloSTAR pen have

been redesigned to improve the user
experience:
– Greater pen capacity for Gla-300 than Gla-100 SoloSTAR
(450 units vs 300 units of insulin glargine)1
– 1 click of the dose selector = 1 units of Gla-300
(i.e. no need for recalculation to account for lower injected
volume)1
– Accurate delivery of insulin units in one-third the volume of
Gla-100 SoloSTAR2

1. Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P

2. Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor)
 Redesigned features of the Gla-300 SoloSTAR® pen

1. Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P

2. Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor)
 Evaluation of the Gla-300 SoloSTAR pen
An insulin device that is easy to use and inject may contribute to
increased adherence to insulin therapy, and therefore improve
glycemic management1
Two clinical studies have evaluated the usability of the Gla-300
SoloSTAR pen:
Clinical study ONE:
• Experienced pen users with T1DM or T2DM and HCPs1
– Interview-based survey in insulin pen users with T1DM or T2DM, HCPs
with experience in prescribing insulin pens and training insulin pen
users conducted in France, Germany, Spain, UK, USA, and Japan
– Gla-300 SoloSTAR was compared with 3 other commercialized
disposable insulin pens

HCP, health care professional; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus
1. Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor)
4
 Evaluation of the Gla-300 SoloSTAR pen

Clinical Study TWO:

• Insulin-naïve people with T2DM1
– 4-week, multi-center, open-label, Phase 3b study in 40
insulin and pen-naïve people with T2DM conducted in
Germany
– Single-arm study with Gla-300 SoloSTAR
ONE laboratory study compared the accuracy and injection
force of the Gla-300 SoloSTAR pen with 2 other commercialized
disposable insulin pens2

1. Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P

2. Klonoff D et al. J Diabetes Sci Technol. 2015 Aug 26. pii: 1932296815601441. [Epub ahead of print]

5
 Usability of the Gla-300 SoloSTAR
compared with three other
commercialized disposable insulin pens:

Results of an interview-based survey

Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor)

6
 Gla-300 SoloSTAR vs
Methods other devices

• Design: Survey consisting of a 75-min face-to-face interview

during which participants:
– Ranked a predefined list of insulin pen features in order of
importance
– Following demonstration of how to use the 4 insulin pens,
each pen was ranked (1st to 4th) according to each
predefined feature
• Location: France, Germany, Spain, UK, USA, and Japan
• Participants: Insulin pen users with T1DM (n=26) or T2DM
(n=228) and HCPs (n=190) with experience in prescribing
insulin pens and training insulin pen users

Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor) 7

 Gla-300 SoloSTAR vs
Methods other devices

• Comparators:
– Gla-300 SoloSTAR pen (Sanofi, Paris, France) -BLINDED

– Gla-100 SoloSTAR pen (Sanofi, Paris, France)

– FlexPen® (Novo Nordisk A/S Bagsværd, Denmark)

– KwikPen™ (Eli Lilly & Co, Indianapolis, IN, USA)

Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor) 8

 Gla-300 SoloSTAR vs
PATIENTS: Most important features other devices

• Of the three features selected as being most important, users ranked Gla-300 SoloSTAR first
for “Easiest to inject yourself” and “Easiest to use overall” more often than other pens
(P<0.001)
• Gla-300 SoloSTAR was ranked first more often than other pens for “Least effort required to
push plunger” (P<0.001), suggesting Gla-300 SoloSTAR may benefit people with reduced
hand strength
• More users ranked Gla-100 SoloSTAR first for “Easiest to see how much insulin is left in
the pen” (P<0.001 vs Gla-300)
• More users ranked FlexPen first for “Easiest to feel and hear the dial turning” (P<0.001 vs Gla-
300)
• More users ranked KwikPen first for “Most discrete” (P<0.01) and “Best size to hold while
injecting” (P<0.05 vs Gla-300)

Percentage of users ranking each pen device in first place

T1DM, n=26; T2DM, n=228

*P<0.05 vs Gla-300 SoloSTAR; **P<0.01 vs Gla-300 SoloSTAR; ***P<0.001 vs Gla-300 SoloSTAR
Adapted from Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor)

9
SAGLB.TJO.15.08.0616 FOR INTERNAL USE ONLY – DO NOT DISTRIBUTE OR USE IN PROMOTION
 HCPs: Most important features Gla-300 SoloSTAR vs
other devices

• Of the three features selected as being most important, trainers ranked Gla-300
SoloSTAR first for “Easiest to use overall” and “Easiest to inject yourself”
more often than other pens (P<0.001)
• Gla-300 SoloSTAR was ranked first more often than other pens for “Least effort
required to push plunger” (P<0.001)
• More HCPs ranked Gla-100 SoloSTAR first for “Easiest to see how much insulin
is left in the pen” (P<0.001 vs Gla-300)
• More HCPs ranked FlexPen first for “Easiest to feel and hear the dial turning”
(P<0.001 vs Gla-300) Percentage of HCPs ranking each pen device in first place

Trainers, n=190
*P<0.05 vs Gla-300 SoloSTAR; **P<0.01 vs Gla-300 SoloSTAR;
***P<0.001 vs Gla-300 SoloSTAR
Adapted from Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8
(Letter to the Editor) 10
SAGLB.TJO.15.08.0616 FOR INTERNAL USE ONLY – DO NOT DISTRIBUTE OR USE IN PROMOTION
 Gla-300 SoloSTAR vs
other devices
Summary
• Limitations include: Single-person interview, the unblinded
nature of the survey for 3 of the tested pens and the use of
newly developed questionnaires (no validation or psychometric
testing)
• Ease of use, ease of self-injection, and ease of dialling the right
dose were perceived to be the most important features of
disposable insulin pens in this interview-based survey

Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor)

11
 Gla-300 SoloSTAR vs
other devices
Summary
• Gla-300 SoloSTAR pen was ranked first by both users and HCPs
involved in the training of insulin pen users significantly more
often than Gla-100 SoloSTAR pen, FlexPen, or KwikPen for ‘Ease
of use overall’ and ‘Easiest to inject yourself’
• Gla-300 SoloSTAR pen was ranked first by both users and HCPs
significantly more often for ‘Least effort required to push
plunger’ vs the 3 other pens

Conclusion

Patients with diabetes and HCPs involved in training insulin

pen users considered the Gla-300 SoloSTAR pen to be easy to
use
Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor)

12
Ease of use of the Gla-300 SoloSTAR in
insulin-naïve people with T2DM

Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P

13
 Gla-300 SoloSTAR in
insulin-naïve T2DM
Objective and methods
• 4-week open-label, single-arm phase 3b study investigated the
use of
Gla-300 SoloSTAR pen in insulin-naïve people with T2DM in
clinical practice
• Location:
– 7 centers in Germany
• Participants (n=40):
– Insulin- and pen-naïve
– Aged ≥18 years with T2DM for ≥1 year
– Receiving OAD for ≥6 months and inadequately controlled
on previous OAD
– HbA1c 7.0–11.0% (53–97 mmol/mol)
HbA1c, glycosylated hemoglobin; OAD, oral antihyperglycemic drugs
Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P
14
 Gla-300 SoloSTAR in
insulin-naïve T2DM
Objective and methods
• Intervention:
– Once-daily Gla-300 SoloSTAR
– Administered in the evening prior to meal (at the
same time of day ± 1 hour throughout the study)
– Starting dose of 0.2 U/kg up-titrated weekly
seeking a fasting self-monitored plasma glucose
target of 80–100 mg/dL (4.4–5.6 mmol/L)

HbA1c, glycosylated hemoglobin; OAD, oral antihyperglycemic drugs

Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P
15
 Gla-300 SoloSTAR in
insulin-naïve T2DM

Methods: Endpoints
• Primary endpoint:1
– Ease of use and ease of learning
• Evaluated by the Ease-of-Use and Ease-of-Learning questionnaire
(scores: 1 [excellent] to 5 [very poor])2
• Secondary endpoints:1
– Treatment satisfaction
• DTSQs total score; scores: 0 [very dissatisfied] to 36 [very satisfied]3
– Change in pre-injection plasma glucose and FPG from baseline to Week
4
– Change in insulin dose from baseline (starting dose) to Week 4
– Reliability (incidence of PTCs or AEs due to PTCs)
– Safety: incidence of hypoglycemia (ADA definitions) and AEs
2. Gottesman I et al. Diabetes Technol Ther. 2012;14:926-35
3. Lewis KS et al. Diabet Med. 1988;5:235-42

AE, adverse event; DTSQ, Diabetes Treatment Satisfaction Questionnaire (status version); FPG, fasting plasma glucose; PTC, product technical complaint
1. Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P 16
 Gla-300
Gla-300SoloSTAR
SoloSTARinin
insulin-naïve
insulin naïve
T2DM

Baseline demographics
Treated population (n=40)
Age, years 66.2 (9.8)
Males, n (%) 19 (47.5)
Weight, kg 88.4 (15.9)
BMI, kg/m2 30.1 (4.4)
HbA1C, % 8.25 (0.80)
HbA1C, mmol/mol 66.7 (8.7)
Diabetes duration, years 10.7 (5.6)

All values are mean (SD), unless otherwise stated

Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P

17
 Gla-300 SoloSTAR in
Improved ease of use and ease of learning insulin-naïve T2DM

• Ease of use and ease of learning scores generally improved (decreased)

during the study
• At Week 4, 95.0% of participants assessed Gla-300 SoloSTAR as excellent or
good overall, compared with 89.7% at baseline
• No participants assessed Gla-300 SoloSTAR as poor or very poor overall at any
visit
• At Week 4, 97.5% of participants said that they would recommend Gla-300
SoloSTAR
Percentage of excellent/good response after 4 weeks of treatment
Ease of use Ease of selecting the dose
Ease of correcting a misdialed dose
Ease of reading the insulin dose
Ease of feeling/hearing dialing clicks
Force/effort needed to inject insulin
Smoothness/gentleness of injection
Ease of knowing if injection is complete
Ease of reading remaining insulin
Ease of learning Ease of learning
General ease of use
Overall assessment
Would you recommend the Gla-300 pen injector?

50 60 70 // 80 90 100
0 10 20 80 90 100
Percentage assessing Gla-300 SoloSTAR as ‘excellent/good’ assessment, or responding Yes to ‘Would you
recommend the Gla-300 pen injector?’ after 4 weeks

Adapted from Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P

18
 Gla-300 SoloSTAR in
insulin-naïve T2DM

No decrease in treatment satisfaction

Change from
Baseline* Week 4 baseline at Week
4
Total DTSQs score 28.2 (5.8) 29.5 (5.6) 1.13 (6.79)

• As total DTSQs score can range from 0 (very dissatisfied) to 36

(very satisfied), the baseline total DTSQs score indicates a good level of
satisfaction with previous OAD therapy
• Total DTSQs score remained stable throughout the study, suggesting no
substantial burden of Gla-300 therapy in this population of previously
insulin-naïve participants

All values are mean (SD)

*Prior to first Gla-300 SoloSTAR dose
Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P
19
 Gla-300 SoloSTAR in
insulin-naïve T2DM
Glycemic control and insulin dose
• Glycemic control improved over the 4-week study, although statistical significance
was not determined
• Mean daily basal insulin dose increased from baseline to Week 4

Change from baseline

Baseline* Week 4
at Week 4
Glycemic control
Pre-injection 206.0 (65.2) 178.3 (53.0) −31.85
plasma glucose, mg/dL 95% CI −52.39 to −11.30
−42.16
FPG, mg/dL 166.1 (35.0) 124.2 (41.1)
95% CI −57.20 to −27.12
Daily insulin dose
0.15
Basal insulin dose, U/kg 0.19 (0.03) 0.34 (0.11)
95% CI 0.11 to 0.18

All values are mean (SD), unless otherwise stated

Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P

20
 Gla-300 SoloSTAR in
insulin-naïve T2DM

• Reliability:
Good reliability and safety
– Participants did not complain about the Gla-300 SoloSTAR pen
• No PTCs or AEs related to PTCs were reported

• Safety:
– 7 (17.5%) participants experienced hypoglycemia corresponding to
5.2 events per participant-year
• Most hypoglycemic events were classified as asymptomatic or
documented symptomatic (≤70 mg/dL [≤3.9 mmol/L])
• No severe hypoglycemia
– Eleven (27.5%) participants experienced treatment-emergent AEs
• Two (5.0%) were injection-site reactions
• None was serious or led to discontinuation or death
– No further local reactions or hypersensitivity reactions were observed

21
Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P
 Gla-300 SoloSTAR in
insulin-naïve T2DM
Summary
In pen-naive and insulin-naive patients with T2DM:
• Gla-300 SoloSTAR pen was considered to be easy to use and easy to learn
• Almost all participants would recommend the Gla-300 SoloSTAR pen
• Treatment satisfaction with previous OAD therapy was good and remained
stable on initiation of the once-daily basal insulin regimen
• Glycemic control improved over the study, although statistical significance
was not determined
• The Gla-300 SoloSTAR pen was perceived to be reliable
• Treatment with Gla-300 was well tolerated
Conclusion
• Over 4 weeks of once-daily dosing, patients with T2DM considered the
Gla-300 SoloSTAR pen to be easy to use and easy to learn
• The Gla-300 SoloSTAR pen was reliable and Gla-300 basal insulin
treatment was both well tolerated and effective

22
Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P
 Accuracy and injection force of the
Gla-300 SoloSTAR compared with other
commercialized disposable insulin pens
Klonoff D et al. J Diabetes Sci Technol. 2015 Aug 26. pii: 1932296815601441. [Epub ahead of
print]

23
 Accuracy and injection force of
Gla-300 SoloSTAR vs

Methods other devices

A laboratory study compared the accuracy and injection force of the

Gla-300 SoloSTAR pen with 2 other commercialized disposable insulin pens
• Design:
– For the accuracy assessment, 60 of each of the 3 tested devices were
used for the delivery of 3 different doses (1 U, half-maximal dose, and
maximal dose), which were measured gravimetrically
– For the injection force assessment, 20 pens of each of the 3 types were
tested twice at half-maximal and once at maximal dose, at an injection
speed of 6 U/s
• Comparators:
– Gla-300 SoloSTAR pen (Sanofi, Paris, France)
– FlexPen® (Novo Nordisk A/S Bagsværd, Denmark)
– KwikPen™ (Eli Lilly & Co, Indianapolis, IN, USA)

Klonoff D et al. J Diabetes Sci Technol. 2015 Aug 26. pii: 1932296815601441. [Epub ahead of print]

24
 Accuracy and injection force of
Dose accuracy Gla-300 SoloSTAR vs
other devices

• All tested pens met the International Organization for Standardization

(ISO) requirements for dosing accuracy

• Between-dose variation was similar for all tested pens, but Gla-300
SoloSTAR showed the lowest between-dose variation (greatest
reproducibility) at all dose levels

Half-maximal dose Maximal dose

(30/40 U) (60/80 U)

Klonoff D et al. J Diabetes Sci Technol. 2015 Aug 26. pii: 1932296815601441. [Epub ahead of print]

25
 Accuracy and injection force of

Injection force Gla-300 SoloSTAR vs

other devices

• Both the mean plateau injection force and the mean maximum injection
force was significantly lower for Gla-300 SoloSTAR than for the other 2 pens
at half maximal and at maximal doses (P<0.0271)

Half-maximal dose (30/40 U) Maximal dose (60/80 U)

*P<0.0271 vs individual pens at both dose levels

Klonoff D et al. J Diabetes Sci Technol. 2015 Aug 26. pii: 1932296815601441. [Epub ahead of print]

26
 Summary: Usability of the Gla-300 SoloSTAR pen
• Adaptations made to the disposable prefilled SoloSTAR insulin pen to
permit delivery of Gla-300, combined with redesign of certain features,
appear to have improved the usability of the injection device1,2
• In a laboratory setting, Gla-300 SoloSTAR pen displayed greater
reproducibility and lowest injection force compared with FlexPen or
KwikPen3
• In an interview-based survey, patients with T1DM or T2DM and HCPs
involved in training insulin pen users considered the Gla-300 SoloSTAR
pen to be easier to use and easier to inject than either Gla-100
SoloSTAR, FlexPen, or KwikPen1

1. Klonoff D et al. J Diabetes Sci Technol. 2015;9:936-8 (Letter to the Editor); 2. Pohlmeier H et al. Poster presentation at ADA 2015;
Abstract 1052-P;
3. Klonoff D et al. J Diabetes Sci Technol. 2015 Aug 26. pii: 1932296815601441. [Epub ahead of print];
27
 Summary: Usability of the Gla-300 SoloSTAR pen
• During a 4-week, phase 3b clinical study, insulin-naïve and insulin-pen
naïve patients with T2DM considered the Gla-300 SoloSTAR pen to be
easy to use, easy to learn, and reliable2
• The majority of participants in the clinical study would recommend the
Gla-300 SoloSTAR pen to others2
• Patients with diabetes can be reluctant to initiate insulin therapy,4,5 yet
treatment satisfaction was maintained in a patient population who were
initiating basal insulin therapy with Gla-300 SoloSTAR pen2

3. Klonoff D et al. J Diabetes Sci Technol. 2015 Aug 26. pii: 1932296815601441. [Epub ahead of print]; 4. Polonsky WH et al. Diabetes
Care. 2005;28:2543-4;
5. Korytkowski M. Int J Obes Relat Metab Disord. 2002;26 Suppl 3:S18-24
28
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