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Completed

NCT Number: NCT03131687

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician., Gdansk, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Dulaglutide

Drug

Administered SC

Other names: LY2189265

Placebo

Drug

Administered SC

Primary outcomes

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

    Time frame: Baseline, Week 26

    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.

Secondary outcomes

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

    Time frame: Baseline, Week 12

    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.

  2. Change From Baseline to Week 26 in HbA1c

    Time frame: Baseline, Week 26

    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.

  3. Change From Baseline to Week 12 in HbA1c

    Time frame: Baseline, Week 12

    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.

  4. Change From Baseline in Body Weight

    Time frame: Baseline, Week 26

    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.

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

    Time frame: Week 26

    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.

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

    Time frame: Week 26

    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.

  7. Percentage of Participants Reaching the HbA1c Target of ≤6.5%

    Time frame: Week 26

    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.

  8. Percentage of Participants Reaching the HbA1c Target of <7.0%

    Time frame: Week 26

    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.

  9. Change From Baseline in Fasting Blood Glucose

    Time frame: Baseline, Week 26

    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.

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

    Time frame: Baseline, Week 26

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

  11. Change From Baseline in Total Cholesterol

    Time frame: Baseline, Week 26

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

  12. Change From Baseline in Triglycerides

    Time frame: Baseline, Week 26

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

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

    Time frame: Baseline, Week 26

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

  14. Change From Baseline in Waist Circumference

    Time frame: Baseline, Week 26

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

  15. Number of Participants With Anti-Drug Antibodies

    Time frame: Baseline through Week 30

    Number of Participants With Anti-Drug Antibodies.

  16. 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

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Study of Once-Weekly LY3298176 Compared With Placebo and Dulaglutide in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2017
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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