Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients.
Alexander Y MayorovAnna A MosikianDiana N AlpenidzeIgor E MakarenkoValeria L OrlovaIvan S LunevMaria V VerbovayaBella R ZinnatulinaAlexander L KhokhlovRoman V DraiPublished in: Journal of comparative effectiveness research (2020)
Aim: To compare safety (immunogenicity) and efficacy of a biosimilar insulin GP-Lis25 and a reference insulin Ly-Lis25 (Humalog Mix 25) in Type 2 diabetes mellitus (T2D) patients. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 210 T2D patients, randomized 1:1 to twice-daily GP-Lis25 or Ly-Lis25. The primary end point was immune response at 26th week. Noninferiority margin for HbA1c was 0.4%. Results: Immune response frequency was similar in GP-Lis25 and Ly-Lis25 groups both at week 12 (p = 0.651) and 26 (p = 0.164). The difference of HbA1c change at week 26 was (95% CI) 0.01 (-0.27-0.28)%. Fasting plasma glucose, seven-point glucose profile and insulin dose were similar between groups. Safety did not differ between groups. Conclusion: GP-Lis25 and Ly-Lis25 demonstrated similar safety and efficacy. ClincalTrials.gov identifier: NCT04023344.
Keyphrases
- end stage renal disease
- open label
- type diabetes
- immune response
- clinical trial
- ejection fraction
- newly diagnosed
- chronic kidney disease
- peritoneal dialysis
- double blind
- prognostic factors
- phase ii
- blood glucose
- randomized controlled trial
- squamous cell carcinoma
- adipose tissue
- dendritic cells
- phase iii
- physical activity
- skeletal muscle
- patient reported
- chemotherapy induced