A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

NCT05275400 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 986

Last updated 2025-06-03

Study results available
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Summary

The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Conditions

Interventions

DRUG

Insulin Efsitora Alfa

Administered SC

DRUG

Insulin Degludec

Administered SC

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2024-05-15
Completion
2024-05-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Hungary
  • Japan
  • Poland
  • Puerto Rico
  • Slovakia
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05275400 on ClinicalTrials.gov