NCT02666430

Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients

An Open-label, Randomized, Multi-center, Parallel-Group Clinical Trial Comparing the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients: An Extension Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Accepted

Summary

The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.

Detailed description

This multi-center, open-label, randomized clinical extension study in patients with T1DM will assess safety and efficacy of Mylan's insulin glargine and Lantus®. Patients with an established diagnosis of T1DM per American Diabetes Association 2014 criteria who were randomized to the Lantus® treatment arm of the Mylan Glargine 3001 study, and who have completed the 52-week treatment period on Lantus® will be eligible to be screened for the MYL-1501D-3003 study.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Mylan's insulin glargine
DRUG	Lantus®

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-03-01
• Completion: 2017-07-01
• First posted: 2016-01-28
• Last updated: 2022-03-03
• Results posted: 2020-09-14

Locations

81 sites across 8 countries: United States, Canada, Czechia, Estonia, Germany, Hungary, Latvia, Slovakia