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)

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 795 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• T2D

Interventions

Type	Name	Description
DRUG	Insulin Efsitora Alfa	Administered SC
DRUG	Insulin Glargine	Administered SC

Timeline

• Start date: 2023-01-14
• Primary completion: 2024-07-19
• Completion: 2024-07-19
• First posted: 2022-12-22
• Last updated: 2025-08-06
• Results posted: 2025-08-06

Locations

71 sites across 4 countries: United States, Argentina, Mexico, Puerto Rico

Regulatory

• FDA-regulated drug study