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

Lilly

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: tirzepatide; Drug: Placebo; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03131687

16335

I8F-MC-GPGB (Other Identifier)

2016-004179-33 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 318 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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318 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Tirzepatide placebo and dulaglutide placebo administered subcutaneously (SC) once weekly.

Treatment:

Drug: Placebo

1 mg Tirzepatide

Experimental group

Description:

1 milligrams (mg) tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Treatment:

Drug: Placebo

Drug: tirzepatide

5 mg Tirzepatide

Experimental group

Description:

5 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Treatment:

Drug: Placebo

Drug: tirzepatide

10 mg Tirzepatide

Experimental group

Description:

10 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Treatment:

Drug: Placebo

Drug: tirzepatide

15 mg Tirzepatide

Experimental group

Description:

15 mg tirzepatide administered SC once weekly. Dulaglutide placebo administered SC once weekly.

Treatment:

Drug: Placebo

Drug: tirzepatide

1.5 mg Dulaglutide

Active Comparator group

Description:

1.5 mg Dulaglutide administered SC once weekly. Tirzepatide placebo administered SC once weekly.

Treatment:

Drug: Placebo

Drug: Dulaglutide