A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.

Key facts

Study ID

NCT04537923

Run by

Eli Lilly and Company

People needed

1428

Starts

2020-10-19

Expected to finish

2022-11-01

Last updated by the study team

2023-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have been diagnosed with type 2 diabetes mellitus (T2DM)
• Have HbA1c between ≥7.5% and ≤11%
• Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors
• Be of stable weight (± 5%) for at least 90 days
• Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 kg/m² at screening

You may not qualify if…

• Have type 1 diabetes mellitus
• Have had chronic or acute pancreatitis any time prior to study entry
• Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
• Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility
• Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
• Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
• Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
• Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)]

Where it is running

• Valley Research — Fresno, California, United States
• National Research Institute - Huntington Park — Huntington Park, California, United States
• National Research Institute - Huntington Park — Los Angeles, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• National Research Institute - Huntington Park — Panorama City, California, United States
• National Research Institute (NRI) - Santa Ana — Santa Ana, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• University of Colorado — Aurora, Colorado, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• I R & Health Center, Inc. — Hialeah, Florida, United States
• Sun Coast Clinical Research, Inc — New Port Richey, Florida, United States
• South Broward Research — Pembroke Pines, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• J H. Stroger Hosp of Cook Co — Chicago, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Capital Diabetes and Endocrine Associates — Camp Springs, Maryland, United States
• MedStar Health Research Institute — Hyattsville, Maryland, United States
• Endocrine and Metabolic Consultants — Rockville, Maryland, United States
• Glacier View Research Institute - Endocrinology — Kalispell, Montana, United States
• Southern Nh Diabetes and Endocrinology — Nashua, New Hampshire, United States
• Albany Medical College — Albany, New York, United States
• Syed Research Consultants Llc — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.