NCT03376789

Mylan Insulin Glargine Study

A Randomized, Multi-center, Double-Blind, Parallel-Group Clinical Study Comparing the Efficacy and Safety of MYL-1501D Produced by Two Manufacturing Processes in Type 1 Diabetes Mellitus Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to demonstrate similar efficacy and safety between MYL-1501D products produced from two manufacturing processes (Process V and Process VI) in combination with insulin lispro in patients with type 1 diabetes mellitus (T1DM).

Detailed description

This is a multicenter, double-blind, randomized, parallel-group Phase 3 study in subjects with type 1 diabetes mellitus (T1DM) comparing the efficacy, immunogenicity, and safety of MYL-1501D products from 2 manufacturing processes (Process V and Process VI). After a 2-week screening period, all subjects will be titrated on Lantus® during a 4-week run-in period and shifted from their current mealtime insulin to insulin lispro (Humalog®). Subjects will then be randomized (stratified by time of administration of glargine \[morning and evening\]) to 1 of 2 groups: * MYL-1501D product from Process V * MYL-1501D product from Process VI Treatment with MYL-1501D is for 18 weeks. A follow-up visit is scheduled 2 weeks after last dose of MYL 1501D.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	MYL-1501D product using manufacture process V	MYL-1501D product using manufacture process V
DRUG	MYL-1501D product using manufacture process VI	MYL-1501D product using manufacture process VI

Timeline

• Start date: 2017-11-29
• Primary completion: 2018-09-25
• Completion: 2019-01-10
• First posted: 2017-12-18
• Last updated: 2022-03-03
• Results posted: 2022-03-03

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated drug study