A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in participants with type 2 diabetes mellitus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide; Immunoglobulin Fc Fragments; Tirzepatide

Criteria

Inclusion Criteria:

• Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification.

• Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.

• If on metformin, have been treated with stable doses of metformin for at least 3 months.

• Have a body mass index (BMI) ≥23 and <50 kilograms per square meter.

Exclusion Criteria:

• Have type 1 diabetes (T1D).

• Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past.

• Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).

• Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.

• Have had chronic or acute pancreatitis any time prior to study entry.

• Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.

• Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.

• Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.