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

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)

NCT05275400•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
•Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
•Have HbA1c value of 6.5% - 10% inclusive, at screening
•Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
•Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
•* once daily U100 or U200 of insulin degludec
•* once daily U100 or U300 of insulin glargine
•* once or twice daily U100 of insulin detemir, or
•* once or twice daily human insulin NPH
•acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
+6 more criteria

Exclusion Criteria

•Have Type 1 diabetes mellitus
•Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
•Estimated glomerular filtration rate (eGFR) \<20 milliliters/minute/1.73 square meter (m²)
•Have active or untreated malignancy
•Are pregnant
•Have a significant weight gain or loss the past 3 months
•Have received anytime in the past 6 months, any of the following insulin therapies:
•* prandial insulin
•* insulin mixtures
•* inhaled insulin
+7 more criteria

Locations (127)

Medical Investigations

Little Rock, Arkansas, United States

John Muir Physician Network Research Center

Concord, California, United States

AMCR Institute

Escondido, California, United States

National Research Institute - Huntington Park

Huntington Park, California, United States

Scripps Whittier Diabetes Institute

La Jolla, California, United States

Diabetes Associates Medical Group

Orange, California, United States

University Clinical Investigators, Inc.

Tustin, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Encore Medical Research

Hollywood, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Key Dates

Start Date

March 8, 2022

Primary Completion Date

May 15, 2024

Completion Date

May 15, 2024

Last Updated

June 3, 2025

Enrollment

986

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Insulin Efsitora Alfa

DRUG

Insulin Degludec

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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