Beruflich Dokumente
Kultur Dokumente
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
5
Usability of the Gla-300 SoloSTAR
compared with three other
commercialized disposable insulin pens:
6
Gla-300 SoloSTAR vs
Methods other devices
• Comparators:
– Gla-300 SoloSTAR pen (Sanofi, Paris, France) -BLINDED
• 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)
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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
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
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Ease of use of the Gla-300 SoloSTAR in
insulin-naïve people with T2DM
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)
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)
17
Gla-300 SoloSTAR in
Improved ease of use and ease of learning insulin-naïve T2DM
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
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
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
• 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
Klonoff D et al. J Diabetes Sci Technol. 2015 Aug 26. pii: 1932296815601441. [Epub ahead of print]
25
Accuracy and injection force of
• 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)
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
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TERIMA KASIH
MARAMING SALAMAT PO
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