A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: LY3938577; Drug: Degludec

• Registration Number: NCT07215312
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-09
• Study First Submitted QC: 2025-10-09
• Last Update Submitted: 2025-10-09
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10
• Study Start: 2025-11-01
• Primary Completion: 2026-11
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Have type 2 diabetes
• Are receiving ≥20 units of basal insulin per day and ≤55 units/day and ≤1.5 units/kg/day at screening
• Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive
• Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg/m2)

Exclusion Criteria

• Have type 1 diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3938577	LY3938577	Participants will receive LY3938577 subcutaneously (SC)
Degludec	Degludec	Participants will receive degludec SC

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis)	Baseline through Week 20

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Superiority Analysis)	Baseline through Week 20
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 20
Pharmacokinetics (PK): Average Concentration of LY3938577	Baseline through Week 20

Trial Locations

Locations (26)

Tucson Clinical Research Institute; 🇺🇸 Tucson, Arizona, United States

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

University Clinical Investigators, Inc.; 🇺🇸 Tustin, California, United States

Tampa Bay Medical Research; 🇺🇸 Clearwater, Florida, United States

Encore Medical Research; 🇺🇸 Hollywood, Florida, United States

Clinical Research of Central Florida; 🇺🇸 Lakeland, Florida, United States

Encore Medical Research - Weston; 🇺🇸 Weston, Florida, United States

Iowa Diabetes and Endocrinology Research Center; 🇺🇸 West Des Moines, Iowa, United States

Washington University School of Medicine; 🇺🇸 St Louis, Missouri, United States

Accellacare - Wilmington; 🇺🇸 Wilmington, North Carolina, United States

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