Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Glargine (Gan & Lee Glargine) Compared With Originator Insulin Glargine (Lantus) in Patients With Type 1 Diabetes After 26 Weeks Treatment

IF 3.7 3区医学 Q2 ENDOCRINOLOGY & METABOLISM Endocrine Practice Pub Date : 2024-09-01 DOI:10.1016/j.eprac.2024.06.002

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Abstract

Objective

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).

Methods

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.

Results

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.

Conclusion

GL Glargine demonstrated similar immunogenicity, efficacy, and safety compared to Lantus over 26 weeks in patients with T1DM.

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生物仿制胰岛素格列宁（甘李格列宁）与原研胰岛素格列宁（Lantus®）在 1 型糖尿病患者中治疗 26 周后的免疫原性、疗效和安全性比较。

目的比较 GL Glargine 与参比产品（Lantus®）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、等效性研究。576名1型糖尿病患者按1:1比例随机接受GL Glargine或Lantus®治疗，疗程26周。主要终点是基线后至第26周的各治疗组中出现治疗诱导的抗胰岛素抗体（AIA）的受试者百分比，采用国家调整的逻辑回归模型进行评估。研究还比较了糖化血红蛋白（HbA1c）的变化以及包括低血糖在内的不良事件（AEs）：到第 26 周时，GL Glargine 治疗组和 Lantus® 治疗组的治疗诱发 AIA 阳性受试者比例分别为 25.8%和 25.3%，比例差异的 90% 置信区间 [CI]（-5.4, 6.5）完全介于相似性边缘（-11.3, 11.3）之间。治疗组间 HbA1c 变化的最小二乘法（LS）平均差异为-0.08（90% CI：-0.23，0.06），其他免疫原性和安全性特征相当：GL Glargine与Lantus®相比，在对T1DM患者进行26周的治疗后，显示出相似的免疫原性、疗效和安全性。

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来源期刊

Endocrine Practice ENDOCRINOLOGY & METABOLISM-

CiteScore

7.60

自引率

2.40%

发文量

546

审稿时长

41 days

期刊介绍： Endocrine Practice (ISSN: 1530-891X), a peer-reviewed journal published twelve times a year, is the official journal of the American Association of Clinical Endocrinologists (AACE). The primary mission of Endocrine Practice is to enhance the health care of patients with endocrine diseases through continuing education of practicing endocrinologists.

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