Christofides Elena A, Stankiewicz Andrzej, Denham Douglas, Bellido Diego, Franek Edward, Nakhle Samer, Łukaszewicz Monika, Reed John, Cózar-León Victoria, Kosch Christine, Karaś Piotr, Fitz-Patrick David, Handelsman Yehuda, Warren Mark, Hollander Priscilla, Huffman David, Raskin Philip, Oroszlán Tamás, Lillestol Michael, Ovalle Fernando
Endocrinology Research Associates, Columbus.
NZOZ Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne "Diab-Endo-Met", Kraków, Poland.
Endocr Pract. 2024 Sep;30(9):810-816. doi: 10.1016/j.eprac.2024.06.002. Epub 2024 Jun 12.
To compare the immunogenicity, safety, and efficacy of Gan & Lee insulin glargine (GL Glargine) with that of the originator insulin glargine (Lantus) in patients with type 1 diabetes mellitus (T1DM).
This was a phase 3, multicenter, randomized, open-label, equivalence study. Five hundred seventy-six subjects with T1DM were randomized 1:1 to receive either GL Glargine or Lantus treatment for 26 weeks. The primary end point was the percentage of subjects in each treatment group who developed treatment-induced anti-insulin antibody after baseline and up to visit week 26, which was evaluated using a country-adjusted logistic regression model. The study also compared the changes in glycated hemoglobin, and adverse events including hypoglycemia.
The percentage of subjects positive for treatment-induced anti-insulin antibody by Week 26 was 25.8% in the GL Glargine treatment group and 25.3% in the Lantus treatment group, with a 90% confidence interval (-5.4, 6.5) of the difference in proportions that fell completely between the similarity margins (-11.3, 11.3). The least squares mean difference between treatment groups for changes in glycated hemoglobin was -0.08 (90% confidence interval: -0.23, 0.06), and the other immunogenicity and safety profiles were comparable.
GL Glargine demonstrated similar immunogenicity, efficacy, and safety compared to Lantus over 26 weeks in patients with T1DM.
比较甘李胰岛素甘精胰岛素（GL甘精胰岛素）与原研甘精胰岛素（来得时）在1型糖尿病（T1DM）患者中的免疫原性、安全性和疗效。
这是一项3期、多中心、随机、开放标签的等效性研究。576例T1DM患者按1:1随机分组，接受GL甘精胰岛素或来得时治疗26周。主要终点是各治疗组中在基线后至第26周访视时出现治疗诱导的抗胰岛素抗体的受试者百分比，使用国家调整的逻辑回归模型进行评估。该研究还比较了糖化血红蛋白的变化以及包括低血糖在内的不良事件。
GL甘精胰岛素治疗组在第26周时治疗诱导的抗胰岛素抗体阳性受试者百分比为25.8%，来得时治疗组为25.3%，比例差异的90%置信区间（-5.4, 6.5）完全落在相似性界限（-11.3, 11.3）之间。治疗组间糖化血红蛋白变化的最小二乘均值差异为-0.08（90%置信区间：-0.23, 0.06），其他免疫原性和安全性特征相当。
在T1DM患者中，GL甘精胰岛素在26周内的免疫原性、疗效和安全性与来得时相似。
