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 (INSTRIDE 1)

NCT02227862 Phase 3 COMPLETED Results posted

To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (based on change in HbA1c from baseline to 24 weeks) when administered in combination with mealtime insulin lispro.

Details

Lead sponsor	Mylan Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	558
Start date	2014-06
Completion	2016-07

Conditions

• Type 1 Diabetes

Interventions

• Mylan's insulin glargine
• Lantus®

Primary outcomes

• Change in HbA1c From Baseline to 24 Weeks — 24 weeks

Countries

United States, Canada, Czechia, Estonia, Germany, Hungary, Latvia, Romania, Slovakia, South Africa, United Kingdom