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.

To compare the immunogenicity, safety, and efficacy of GL Glargine with that of the reference product (Lantus®) in patients with type 1 diabetes mellitus (T1DM). This was a Phase 3, multicenter, randomized, open-label, equivalence study. 576 subjects with T1DM were randomized 1:1 to receive either GL Glargine or Lantus® treatment for 26 weeks. The primary endpoint was the percentage of subjects in each treatment group who developed treatment-induced anti-insulin antibody (AIA) 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 (HbA1c), and adverse events (AEs) including hypoglycemia. The percentage of subjects positive for treatment-induced AIA 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 [CI] (-5.4, 6.5) of the difference in proportions that fell completely between the similarity margins (-11.3, 11.3). The least squares (LS) mean difference between treatment groups for changes in HbA1c was -0.08 (90% CI: -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.

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.