A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus

Phase 3 Completed 272 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM).

Timeline

Start: 2018-03-23
Primary completion: 2020-03-05
Completion: 2020-03-05

Outcome

Met primary endpoint

paper demonstrated comparable efficacy and safety versus the reference product in Chinese patients with type 1 diabetes mellitus (T1DM) in the randomized, phase III ABES trial. PMID 35471721 ↗

Publications

Yan X, Feng C, Lou Y, Zhou Z. Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (Lantus(R)): a Post Hoc Analysis of a Randomized, Open-Label, Phase 3 Trial. Diabetes Ther. 2022 Jun;13(6):1161-1174. doi: 10.1007/s13300-022-01262-8. Epub 2022 Apr 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LY2963016	Protein / enzyme biologic	100 iu	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	100 iu	Subcutaneous
Background	Insulin Lispro	Protein / enzyme biologic	100 iu	Subcutaneous