Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients.

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.

A phase 3 randomized placebo-controlled trial to assess the efficacy and safety of ipragliflozin as an add-on therapy to metformin in Russian patients with inadequately controlled type 2 diabetes mellitus.

AIM: To assess the efficacy and safety of ipragliflozin as add-on therapy to metformin in Russian patients with type 2 diabetes mellitus. METHODS: In this double-blind study conducted in 14 centers in Russia, 165 patients were randomized 2:1 to ipragliflozin (50 mg/day) or placebo for 24 weeks while continuing metformin. Patients who had HbA1c ≥ 7.0% (53 mmol/mol) at Week 12 received open-label ipragliflozin (50 mg/day) in addition to the blinded drug from Week 12-24. RESULTS: Significant reductions in HbA1c and body weight from baseline to Week 12 in favor of ipragliflozin were observed (adjusted mean difference to placebo: -0.3% (-3 mmol/mol), P = 0.048 and -1.34 kg, P < 0.001, respectively). The incidence of AEs was similar in both groups. Uptitration to 100 mg/day ipragliflozin led to a further reduction in body weight (mean change from Week 12: -0.65 kg, P = 0.004) and an additional 13% (9/69) of patients achieving HbA1c < 7.0% (53 mmol/mol) at Week 24. Incidence of AEs was similar among patients receiving ipragliflozin 50 mg/day (23.7%) and 100 mg/day (24.6%). CONCLUSION: Ipragliflozin 50 mg/day added to metformin significantly reduced HbA1c and body weight after 12 weeks and showed a safety profile comparable to placebo. Uptitration to 100 mg/day improved clinical outcomes with no additional safety concerns.