1. 729-P: Efficacy and Safety of Mylan Insulin Glargine Products (MYL-1501D) from Two Manufacturing Processes (Process V and Process VI) in Combination with Insulin Lispro in Subjects with Type 1 Diabetes Mellitus

Abstract:

This was a multicenter, double-blind, 18-week Phase 3 study to evaluate the efficacy and safety between MYL-1501D (Mylan insulin glargine) products from two manufacturing processes (Process V and Process VI), in combination with insulin lispro in subjects with T1DM. Process VI includes an additional chromatographic separation at a different production site. The primary endpoint was to demonstrate non-inferiority of product from Process VI to Process V based on the change in glycosylated hemoglobin (HbA1c) from baseline to Week 18. Secondary endpoints included change in fasting plasma glucose, basal-, meal-time-, and total- insulin dose and safety parameters. A total of 219 subjects were randomized in 1:1 ratio and were analyzed for the primary endpoint (ITT population) and, 218 subjects were analyzed for safety. The study met its primary endpoint, and the upper limit of the 2 sided 95% CI for the difference of mean change in HbA1c between the two products was <0.4%. Other efficacy endpoints support the non-inferiority finding (Table 1). MYL-1501D from Process VI demonstrated similarity to Process V in the efficacy and safety profiles (including the immunogenicity, hypoglycemia rate, local/systemic reactions, and other adverse events).