Mylan Insulin Aspart Study

Summary

The aim of this phase III trial is to demonstrate the equivalence in the safety and efficacy profile between MYL-1601D and NovoLog® in patients with T1DM.

Timeline

Start

2018-11-07

Primary completion

2019-12-28

Completion

2020-01-17

Publications

• Blevins TC, Raiter Y, Sun B, Donnelly C, Shapiro R, Chullikana A, Rao A, Vashishta L, Ranganna G, Barve A. Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog(R)) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study. BioDrugs. 2022 Nov;36(6):761-772. doi: 10.1007/s40259-022-00554-6. Epub 2022 Sep 17.

Drugs

Indications