Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes: A randomized, open-label clinical trial

2018 ◽  
Vol 20 (9) ◽  
pp. 2220-2228 ◽  
Author(s):  
Philip D. Home ◽  
Raymond L. H. Lam ◽  
Wendy L. Carofano ◽  
Gregory T. Golm ◽  
Roy Eldor ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Type 1 Diabetes ◽  
Insulin Glargine ◽  
Efficacy And Safety ◽  
Open Label

Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus®): a randomized open-label clinical trial

2020 ◽  
Vol 9 (4) ◽  
pp. 263-273
Author(s):  
Tatiana L Karonova ◽  
Anna A Mosikian ◽  
Alexander Y Mayorov ◽  
Igor E Makarenko ◽  
Svetlana T Zyangirova ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Trial ◽  
Immune Response ◽  
Type 1 Diabetes ◽  
Insulin Glargine ◽  
Open Label ◽  
Once Daily ◽  
Safety And Efficacy ◽  
Glucose Profiles

Aim: To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus® (Sanofi glargine, Sa-Gla) in people with diabetes mellitus. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 180 Type 1 diabetes mellitus patients (HbA1c 6.5–12.0%), randomized 1:1 to once daily GP-Gla (n = 90) or Sa-Gla (n = 90). The primary end point was immune response at 26th week. Results: The frequency of immune response was similar in GP-Gla and Sa-Gla (p = 1.000). Groups were similar in terms of other safety end points. Mean HbA1c change from baseline was -0.66% for GP-Gla and -0.77% for Sa-Gla, and did not differ between groups (p = 0.326). Insulin doses, fasting plasma glucose and seven-point glucose profiles were similar between groups. Conclusion: GP-Gla and Sa-Gla demonstrated similar safety and efficacy. ClinicalTrials.gov Identifier: NCT04022993

scholarly journals New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 1 Diabetes: A Randomized, Phase 3a, Open-Label Clinical Trial (EDITION 4)

Diabetes Care ◽  
2015 ◽  
Vol 38 (12) ◽  
pp. 2217-2225 ◽  
Author(s):  
Philip D. Home ◽  
Richard M. Bergenstal ◽  
Geremia B. Bolli ◽  
Monika Ziemen ◽  
Maria Rojeski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Type 1 Diabetes ◽  
Insulin Glargine ◽  
Open Label
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