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

Eli Lilly and Company318 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

318

Conditions

Type 2 Diabetes Mellitus

Interventions

tirzepatideDRUG

Administered SC

DulaglutideDRUG

Administered SC

PlaceboDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (49)

Outcomes

Primary Outcomes

Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response

HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.

Time frame: Baseline, Week 26

Secondary Outcomes

Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response

HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline. The Least Squares Mean is Posterior mean.

Time frame: Baseline, Week 12

Change From Baseline to Week 26 in HbA1c

HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.

Time frame: Baseline, Week 26

Change From Baseline to Week 12 in HbA1c

Time frame: Baseline, Week 12

Change From Baseline in Body Weight

Data from ClinicalTrials.gov

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Internal Medicine Center LLC

Mobile, Alabama, United States

Anaheim Clinical Trails

Anaheim, California, United States

Valley Research

Fresno, California, United States

National Research Institute

Huntington Park, California, United States

National Research Institute

Los Angeles, California, United States

Catalina Research Institute

Montclair, California, United States

Valley Clinical Trails, Inc

Northridge, California, United States

Artemis Institute For Clinical Research

San Diego, California, United States

Artemis Institute For Clinical Research

San Marcos, California, United States

Encompass Clinical Research

Spring Valley, California, United States

...and 39 more locations

Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.

Time frame: Baseline, Week 26

Percentage of Participants With 5% or Greater Body Weight Loss From Baseline

Percentage of participants with 5% or greater body weight loss from baseline last observation carried forward (LOCF) analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.

Time frame: Week 26

Percentage of Participants With 10% or Greater Body Weight Loss From Baseline

Percentage of participants with 10% or greater body weight loss from baseline LOCF analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.

Time frame: Week 26

Percentage of Participants Reaching the HbA1c Target of ≤6.5%

Percentage of participants with HbA1c ≤6.5% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.

Time frame: Week 26

Percentage of Participants Reaching the HbA1c Target of <7.0%

Percentage of participants with HbA1c \<7.0% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.

Time frame: Week 26

Change From Baseline in Fasting Blood Glucose

Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment\*Time.

Time frame: Baseline, Week 26

Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)

LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag,Treatment, time, treatment\*time.

Time frame: Baseline, Week 26

Change From Baseline in Total Cholesterol

LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.

Time frame: Baseline, Week 26

Change From Baseline in Triglycerides

LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.

Time frame: Baseline, Week 26

Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.

Time frame: Baseline, Week 26

Change From Baseline in Waist Circumference

LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment\*Time.

Time frame: Baseline, Week 26

Number of Participants With Anti-Drug Antibodies

Number of Participants With Anti-Drug Antibodies.

Time frame: Baseline through Week 30

Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide

Time frame: Predose: Week 1,8,12 and 26; Postdose: Week 1,2,4 and 12