Diabetes institution, Endocrinology Research Centre, Moscow, Russia.
Department of Clinical trial, OOO GEROPHARM, Saint Petersburg, Russia.
J Comp Eff Res. 2021 Jan;10(1):55-66. doi: 10.2217/cer-2020-0064. Epub 2020 Dec 23.
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. 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%. 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. GP-Lis25 and Ly-Lis25 demonstrated similar safety and efficacy. ClincalTrials.gov identifier: NCT04023344.
比较生物类似胰岛素 GP-Lis25 和参照胰岛素 Ly-Lis25（Humalog Mix 25）在 2 型糖尿病（T2DM）患者中的安全性（免疫原性）和疗效。这项随机、开放标签、26 周的临床试验纳入了 210 例 T2DM 患者，按 1:1 比例随机分为每日两次接受 GP-Lis25 或 Ly-Lis25 治疗。主要终点为第 26 周的免疫应答。HbA1c 的非劣效性边界为 0.4%。在第 12 周（p=0.651）和第 26 周（p=0.164），GP-Lis25 和 Ly-Lis25 组的免疫应答频率相似。第 26 周时 HbA1c 变化的差异为（95%CI）0.01（-0.27-0.28）%。空腹血糖、七点血糖谱和胰岛素剂量在两组间相似。两组间的安全性无差异。GP-Lis25 和 Ly-Lis25 表现出相似的安全性和疗效。临床试验注册编号：NCT04023344。
