NCT05462756

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

A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 730 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Type 2 Diabetes Treated With Insulin

Interventions

Type	Name	Description
DRUG	Insulin Efsitora Alfa	Administered SC
DRUG	Insulin Lispro (U100)	Administered SC
DRUG	Insulin Glargine (U100)	Administered SC

Timeline

• Start date: 2022-08-11
• Primary completion: 2024-02-27
• Completion: 2024-02-27
• First posted: 2022-07-18
• Last updated: 2025-04-27
• Results posted: 2025-04-27

Locations

81 sites across 8 countries: United States, Argentina, Germany, India, Italy, Mexico, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study