A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin
A Phase 2, Randomized, Open-Label, Comparator-Controlled Trial to Evaluate the Efficacy and Safety of LY3938577 in Study Participants, With Type 2 Diabetes Previously Treated With Basal Insulin
2 other identifiers
interventional
100
2 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus-type-2
Started Oct 2025
Typical duration for phase_2 diabetes-mellitus-type-2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2025
CompletedFirst Posted
Study publicly available on registry
October 10, 2025
CompletedStudy Start
First participant enrolled
October 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 17, 2026
April 1, 2026
1.1 years
October 9, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis)
Baseline through Week 20
Secondary Outcomes (3)
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
Study Arms (2)
LY3938577
EXPERIMENTALParticipants will receive LY3938577 subcutaneously (SC)
Degludec
ACTIVE COMPARATORParticipants will receive degludec SC
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Have type 1 diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Tucson Clinical Research Institute
Tucson, Arizona, 85712, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Encore Medical Research
Hollywood, Florida, 33024, United States
Clinical Research of Central Florida
Lakeland, Florida, 33805, United States
Encore Medical Research - Weston
Weston, Florida, 33331, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401, United States
AMR Clinical
Norman, Oklahoma, 73069, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Juno Research
Houston, Texas, 77040, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
Cicemo Srl
Buenos Aires, 1424, Argentina
CIPREC
Buenos Aires, C1119ACN, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC, Argentina
Instituto Centenario
CABA, 1204, Argentina
Instituto Médico Catamarca IMEC
Rosario, 2000, Argentina
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2025
First Posted
October 10, 2025
Study Start
October 13, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.