Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients

Phase 3 Completed 210 enrolled Geropharm

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is designed to approve non-inferior efficacy and safety of Insulin Lispro Biphasic 25 ("Geropharm") compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients.

Timeline

Start: 2018-03-14
Primary completion: 2019-01-15
Completion: 2019-04-18

Publications

Mayorov AY, Mosikian AA, Alpenidze DN, Makarenko IE, Orlova VL, Lunev IS, Verbovaya MV, Zinnatulina BR, Khokhlov AL, Drai RV. Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients. J Comp Eff Res. 2021 Jan;10(1):55-66. doi: 10.2217/cer-2020-0064. Epub 2020 Dec 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Humalog® Mix25	Protein / enzyme biologic	—	Subcutaneous
Subject	Insulin Lispro Biphasic 25	Unknown	—	Subcutaneous

Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients

Summary

Timeline

Publications

Drugs

Indications