A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Phase 2 Completed 278 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.

Timeline

Start: 2020-07-01
Primary completion: 2021-10-08
Completion: 2021-10-08

Outcome

Met primary endpoint

paper BIF demonstrated a noninferior HbA1c change from baseline versus degludec, with a treatment difference of 0.06% (90% CI -0.11, 0.24; P = 0.56). PMID 36944059 ↗

Publications

Bue-Valleskey JM, Kazda CM, Ma C, Chien J, Zhang Q, Chigutsa E, Landschulz W, Haupt A, Frias JP. Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial. Diabetes Care. 2023 May 1;46(5):1060-1067. doi: 10.2337/dc22-2396.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin Efsitora Alfa	Protein / enzyme biologic	—	Subcutaneous
Comparator	insulin degludec	Protein / enzyme biologic	10 iu	Subcutaneous