A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections
Summary
The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.
Timeline
- Start
- 2022-08-11
- Primary completion
- 2024-02-27
- Completion
- 2024-02-27
Outcome
Met primary endpoint
paper The change from baseline to week 26 using the treatment regimen estimand was -1·01 percentage points for the efsitora group and -1·00 percentage points for the glargine U100 group, indicating non-inferiority of efsitora versus glargine U100. PMID 40562048 ↗
release “Efsitora met the primary endpoint in both QWINT-2 and QWINT-4 with once-a-week dosing regimen for people living with type 2 diabetes” 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.
- Blevins T, Dahl D, Perez Manghi FC, Murthy S, Ortiz Carrasquillo R, Li X, Chang AM, Carr MC, Katz M. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. Lancet. 2025 Jun 28;405(10497):2290-2301. doi: 10.1016/S0140-6736(25)01069-4. Epub 2025 Jun 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin Efsitora Alfa | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |
| Background | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |