NCT05362058

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

A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 928 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Type 2 Diabetes

Interventions

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

Timeline

• Start date: 2022-06-03
• Primary completion: 2024-04-10
• Completion: 2024-04-10
• First posted: 2022-05-05
• Last updated: 2025-05-16
• Results posted: 2025-05-16

Locations

113 sites across 11 countries: United States, Brazil, Canada, China, Czechia, Germany, Greece, Japan, Mexico, Puerto Rico, South Korea

Regulatory

• FDA-regulated drug study