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

Lilly

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03311724

I8F-MC-GPGF (Other Identifier)

16860

Details and patient eligibility

About

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

Enrollment: 111 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (American Diabetes Association 2017).
• 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) between 23 and 45 (Inclusive) 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 12 months.
• 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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111 participants in 4 patient groups, including a placebo group

4,8,12mg Tirzepatide

Experimental group

Description:

Participants received Tirzepatide by subcutaneous (SC) injection in three dose escalations starting with 4 milligrams (mg) for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.

Treatment:

Drug: Tirzepatide

2.5,5,10,15mg Tirzepatide

Experimental group

Description:

Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.

Treatment:

Drug: Tirzepatide

2.5,7.5,15mg Tirzepatide

Experimental group

Description:

Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Placebo administered by SC injection.

Treatment:

Drug: Placebo