AimTo evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus.MethodsThis was a phase 3, multicenter, open‐label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks. The primary endpoint was the proportion of participants in each treatment arm who manifested treatment‐induced anti‐insulin antibodies (AIA). Secondary endpoints included efficacy and safety metrics, changes in glycated haemoglobin levels, and a comparative assessment of adverse events. Results were analysed using an equivalence test comparing the limits of the 90% confidence interval (CI) for treatment‐induced AIA development to the prespecified margins.ResultsThe percentages of participants positive for treatment‐induced glycated haemoglobin by week 26 were similar between the GL Glargine (19.2%) and Lantus® (21.3%) treatment groups, with a treatment difference of −2.1 percentage points and a 90% CI (−7.6%, 3.5%) (predefined similarity margins: −10.7%, 10.7%). The difference in glycated haemoglobin was −0.08% (90% CI, −0.23, 0.06). The overall percentage of participants with any treatment‐emergent adverse events was similar between the GL Glargine (80.1%) and Lantus® (81.6%) treatment groups.ConclusionsGL Glargine was similar to Lantus® in terms of immunogenicity, efficacy, and safety, based on the current study.

中文翻译：

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生物仿制药甘精胰岛素（Gan & Lee glargine）与原研药甘精胰岛素 (Lantus®) 相比，治疗 26 周后 2 型糖尿病患者的免疫原性、有效性和安全性：一项随机开放标签研究

目的评估甘李 (GL) 甘精胰岛素（Basalin®；甘李药业）与参比产品 (来得时®) 在 2 型糖尿病成年参与者中的免疫原性、安全性和有效性的等效性。方法这是一个阶段3、在 57 个地点进行的多中心、开放标签、等效性试验。总共 567 名 2 型糖尿病患者以 1:1 的比例随机接受 GL 甘精胰岛素或来得时®治疗 26 周。主要终点是每个治疗组中表现出治疗诱导的抗胰岛素抗体（AIA）的参与者比例。次要终点包括功效和安全性指标、糖化血红蛋白水平的变化以及不良事件的比较评估。使用等效检验对结果进行分析，将治疗引起的 AIA 发展的 90% 置信区间 (CI) 限制与预先指定的界限进行比较。结果 26 周时，GL 甘精胰岛素治疗引起的糖化血红蛋白呈阳性的参与者百分比相似(19.2%) 和来得时® (21.3%) 治疗组，治疗差异为 -2.1 个百分点，90% CI (-7.6%, 3.5%)（预定义的相似性边界：-10.7%, 10.7%）。糖化血红蛋白的差异为-0.08% (90% CI, -0.23, 0.06)。 GL 甘精胰岛素 (80.1%) 和来得时® (81.6%) 治疗组中出现任何治疗相关不良事件的参与者总体百分比相似。结论 GL 甘精胰岛素在免疫原性、功效和安全性方面与来得时®相似。就目前的研究而言。