A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Phase 2 Completed 399 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.

Timeline

Start: 2018-11-15
Primary completion: 2020-02-18
Completion: 2020-02-18

Outcome

Met primary endpoint

paper The pooled BIF analysis achieved non-inferiority versus degludec for the treatment difference in HbA1c (0·1% [90% CI -0·1 to 0·3]). PMID 36758572 ↗

Publications

Frias J, Chien J, Zhang Q, Chigutsa E, Landschulz W, Syring K, Wullenweber P, Haupt A, Kazda C. Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study. Lancet Diabetes Endocrinol. 2023 Mar;11(3):158-168. doi: 10.1016/S2213-8587(22)00388-6. Epub 2023 Feb 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin Efsitora Alfa	Protein / enzyme biologic	—	Subcutaneous
Comparator	insulin degludec	Protein / enzyme biologic	—	Subcutaneous