drugset / Trial / NCT05662332
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.
Timeline
- Start
- 2023-01-14
- Primary completion
- 2024-07-19
- Completion
- 2024-07-19
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.
- Rosenstock J, Bailey T, Connery L, Miller E, Desouza C, Wang Q, Leohr J, Knights A, Carr MC, Child CJ; QWINT-1 trial investigators. Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. N Engl J Med. 2025 Jul 24;393(4):325-335. doi: 10.1056/NEJMoa2502796. Epub 2025 Jun 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin Efsitora Alfa | Protein / enzyme biologic | 100 iu | Subcutaneous |
| Subject | Insulin Efsitora Alfa | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Subject | Insulin Efsitora Alfa | Protein / enzyme biologic | 250 iu | Subcutaneous |
| Subject | Insulin Efsitora Alfa | Protein / enzyme biologic | 400 iu | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |