A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.

Key facts

Study ID

NCT03730662

Run by

Eli Lilly and Company

People needed

2002

Starts

2018-11-20

Expected to finish

2021-04-22

Last updated by the study team

2022-02-14

Who can join

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

You may qualify if…

• Participants must:
• Have been diagnosed with type 2 diabetes mellitus (T2DM)
• Have HbA1c between ≥7.5% and ≤10.5%
• Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening
• Have increased risk for cardiovascular (CV) events
• Be of stable weight (± 5%)
• Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

You may not qualify if…

• Participants must not:
• Have type 1 diabetes mellitus
• Have had chronic or acute pancreatitis any time prior to study entry
• Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
• Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
• Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
• 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 any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 3 months
• Have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Where it is running

• Valley Clinical Trials, Inc. — Covina, California, United States
• Marin Endocrine Associates — Greenbrae, California, United States
• National Research Institute — Huntington Park, California, United States
• Scripps Whittier Diabetes Institute — La Jolla, California, United States
• First Valley Medical Group — Lancaster, California, United States
• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Monterey Endocrine & Diabetes Institute, Inc. — Monterey, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Desert Medical Group Inc — Palm Springs, California, United States
• Havana Research Institute — Pasadena, California, United States
• Western University of Health Sciences — Pomona, California, United States
• LCGK Research — San Carlos, California, United States
• Olive View Medical Center — Sylmar, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Touro University — Vallejo, California, United States
• Coastal Metabolic Research Centre — Ventura, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• Advanced Pharma Research — Cutler Bay, Florida, United States
• South Florida Wellness & Clinical Research Institute — Margate, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Advanced Research Center — Anaheim, California, United States

Full record on ClinicalTrials.gov

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