A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time
Summary
The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.
Timeline
- Start
- 2022-06-03
- Primary completion
- 2024-04-10
- Completion
- 2024-04-10
Outcome
Met primary endpoint
paper In adults with type 2 diabetes who had not previously received insulin, once-weekly efsitora was noninferior to once-daily degludec in reducing glycated hemoglobin levels. PMID 39254740 ↗
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
- Kiyosue A, Inoue M, Takita Y, Nasu R, Watada H. Efficacy and Safety of Insulin Efsitora Versus Degludec in Adults with Type 2 Diabetes Who Are Insulin-Naive: Japan Subgroup Analysis of QWINT-2. Diabetes Ther. 2026 May;17(5):771-785. doi: 10.1007/s13300-026-01860-w. Epub 2026 May 24.
- 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.
- Wysham C, Bajaj HS, Del Prato S, Franco DR, Kiyosue A, Dahl D, Zhou C, Carr MC, Case M, Firmino Goncalves L; QWINT-2 Investigators. Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. N Engl J Med. 2024 Dec 12;391(23):2201-2211. doi: 10.1056/NEJMoa2403953. Epub 2024 Sep 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin Efsitora Alfa | Protein / enzyme biologic | 500 iu | Subcutaneous |
| Comparator | insulin degludec | Protein / enzyme biologic | 100 iu | Subcutaneous |