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

NCT02666430 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	Mylan Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	127
Start date	2015-12
Completion	2017-07

Conditions

• Type 1 Diabetes Mellitus

Interventions

• Mylan's insulin glargine
• Lantus®

Primary outcomes

• Change in Hemoglobin A1c (HbA1c) From Baseline — Baseline to 36 weeks

Countries

United States, Canada, Czechia, Estonia, Germany, Hungary, Latvia, Slovakia