LY3938577 versus insulin degludec for people 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
PHASE2 · Eli Lilly and Company · NCT07215312
This test will see if LY3938577 controls blood sugar and is as safe as insulin degludec in people with type 2 diabetes who are already taking basal insulin.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company (industry) |
| Locations | 26 sites (Tucson, Arizona and 25 other locations) |
| Trial ID | NCT07215312 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares LY3938577 to insulin degludec over about 26 weeks in adults with type 2 diabetes who were previously treated with basal insulin. Eligible participants must be using 20–55 units/day (and ≤1.5 units/kg/day) of basal insulin at screening, have HbA1c between 7.5% and 10.5%, and a BMI of 20 to <35 kg/m2. The study will monitor glycemic control and safety outcomes including episodes of hypoglycemia and hyperglycemia while participants receive either LY3938577 or degludec. Visits and dosing adjustments occur at clinical research sites in Arizona and California with regular monitoring throughout the treatment period.
Who should consider this trial
Good fit: Adults with type 2 diabetes who are on basal insulin at 20–55 units per day (≤1.5 units/kg/day), have HbA1c 7.5–10.5%, and a BMI of 20–<35 kg/m2 are the intended participants.
Not a fit: People with type 1 diabetes, those taking more than 55 units/day of basal insulin or with BMI ≥35 kg/m2, or with HbA1c outside 7.5–10.5% are unlikely to qualify or benefit from this study.
Why it matters
Potential benefit: If successful, LY3938577 could provide an alternative basal insulin with similar or improved blood sugar control and safety, potentially reducing hypoglycemia risk.
How similar studies have performed: Other licensed basal insulin analogs such as degludec and glargine have shown improved glycemic control and reduced hypoglycemia, but LY3938577 is a newer Lilly compound with limited published Phase 2 data so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tucson, Arizona and 25 other locations
- Tucson Clinical Research Institute — Tucson, Arizona, United States (RECRUITING)
- Encompass Clinical Research — Spring Valley, California, United States (RECRUITING)
- University Clinical Investigators, Inc. — Tustin, California, United States (RECRUITING)
- Tampa Bay Medical Research — Clearwater, Florida, United States (RECRUITING)
- Encore Medical Research — Hollywood, Florida, United States (RECRUITING)
- Clinical Research of Central Florida — Lakeland, Florida, United States (RECRUITING)
- Encore Medical Research - Weston — Weston, Florida, United States (RECRUITING)
- Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States (RECRUITING)
- Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)
- Accellacare - Wilmington — Wilmington, North Carolina, United States (RECRUITING)
- AMR Clinical — Norman, Oklahoma, United States (RECRUITING)
- Tribe Clinical Research, LLC — Greenville, South Carolina, United States (RECRUITING)
- Holston Medical Group — Bristol, Tennessee, United States (RECRUITING)
- Texas Diabetes & Endocrinology, P.A. — Austin, Texas, United States (RECRUITING)
- Velocity Clinical Research, Dallas — Dallas, Texas, United States (RECRUITING)
- Juno Research — Houston, Texas, United States (RECRUITING)
- Southern Endocrinology Associates — Mesquite, Texas, United States (RECRUITING)
- Consano Clinical Research, LLC — Shavano Park, Texas, United States (RECRUITING)
- Texas Valley Clinical Research — Weslaco, Texas, United States (RECRUITING)
- Chrysalis Clinical Research — St. George, Utah, United States (RECRUITING)
- Cicemo Srl — Buenos Aires, Argentina (RECRUITING)
- CIPREC — Buenos Aires, Argentina (RECRUITING)
- Mautalen Salud e Investigación — Buenos Aires, Argentina (RECRUITING)
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires, Argentina (RECRUITING)
- Instituto Centenario — CABA, Argentina (RECRUITING)
- Instituto Médico Catamarca IMEC — Rosario, Argentina (RECRUITING)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, Glycemic control, Hypoglycemia, Hyperglycemia