A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Semaglutide; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03951753

I8F-MC-GPGT (Other Identifier)

17091

2018-003343-37 (EudraCT Number)

Details and patient eligibility

About

This is a study for participants with type 2 diabetes mellitus. The main purpose of this study is to learn more about how tirzepatide, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks, including a 28-week treatment period.

Enrollment: 117 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have T2DM for at least 6 months
• Treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry
• Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin
• Have a body mass index (BMI) between 25 and 45 kilograms per square meter (kg/m² ) inclusive, at screening; are of stable weight (±5%) >3 months prior to screening

Exclusion criteria

• Have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (<1.5 years) ophthalmologic examination
• Impaired renal estimated glomerular filtration rate (eGFR) <45 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
• Have a history or current cardiovascular, respiratory, hepatic, renal, GI,endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 3 patient groups, including a placebo group

Tirzepatide 15 mg

Experimental group

Description:

Participants received 15 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 28 weeks.

Treatment:

Drug: Tirzepatide

Semaglutide 1 mg

Active Comparator group

Description:

Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.

Treatment:

Drug: Semaglutide

Placebo

Placebo Comparator group

Description:

Participants received Placebo administered SC once weekly for 28 weeks.

Treatment:

Drug: Placebo