A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

Summary

The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Timeline

Start

2022-03-08

Primary completion

2024-05-15

Completion

2024-05-15

Outcome

Met primary endpoint

paper estimated treatment difference -0·09 percentage points [95% CI -0·19 to 0·01]), indicating non-inferiority of efsitora to degludec. PMID 40562047 ↗

release “The QWINT-3 trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 26.” lilly.com ↗

Publications

• Miller E, Davidson MB, Bajaj HS, Rosenstock J, Philis-Tsimikis A, Bergenstal RM, Case M, Ilag L, Threlkeld R, Levasseur E, Gelsey F. Evaluation of Overall Health State, Treatment Burden, and Satisfaction with Insulin Efsitora Alfa (Efsitora) vs. Daily Comparator in Adults with Type 2 Diabetes in the QWINT Clinical Trial Program. Diabetes Ther. 2026 Mar;17(3):431-447. doi: 10.1007/s13300-025-01833-5. Epub 2026 Jan 27.
• Philis-Tsimikas A, Bergenstal RM, Bailey TS, Jinnouchi H, Thrasher JR, Ilag L, Mitra J, Syring K, Threlkeld RJ. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. Lancet. 2025 Jun 28;405(10497):2279-2289. doi: 10.1016/S0140-6736(25)01044-X. Epub 2025 Jun 22.

Drugs

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

Indications