drugset / Trial / NCT03376789

Mylan Insulin Glargine Study

NCT03376789 ↗

Phase 3 Completed 219 enrolled Mylan Inc.
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2017-11-29
Primary completion
2018-09-25
Completion
2019-01-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator insulin glargine Protein / enzyme biologic — —