drugset / Trial / NCT03376789
Mylan Insulin Glargine Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | insulin glargine | Protein / enzyme biologic | — | — |