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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-28

Study Completion Date

2021-04-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tirzepatide 15 mg

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

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Semaglutide 1 mg

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

Group Type ACTIVE_COMPARATOR

Semaglutide

Intervention Type DRUG

Administered SC

Placebo

Participants received Placebo administered SC once weekly for 28 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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Tirzepatide

Administered SC

Intervention Type DRUG

Semaglutide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3298176

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No