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Completed

NCT Number: NCT03311724

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

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

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Key information

Conditions

Type 2 Diabetes 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

Valley Research, Fresno, California, United States

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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 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.

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

Primary outcomes

  1. Change From Baseline in Haemoglobin A1c (HbA1c)

    Time frame: Baseline, 3 Months

    Least squares (LS) mean was calculated using mixed model repeated measures model (MMRM) with baseline + baseline BMI group + baseline metformin flag + treatment + time + treatment*time as fixed factors.

Secondary outcomes

  1. Percentage of Participants Achieving HbA1c Target of <7.0%

    Time frame: 3 Months

    Percentage of participants achieving HbA1c target of < (less than) 7.0%.

  2. Change From Baseline in Fasting Blood Glucose (FBG)

    Time frame: Baseline, 3 Months

    LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.

  3. Change From Baseline in Body Weight

    Time frame: Baseline, 3 Months

    LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.

  4. Change From Baseline in Waist Circumference

    Time frame: Baseline, 3 Months

    LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.

  5. Number of Participants With Anti Drug Antibodies

    Time frame: Baseline through 3 Months

    Number of participants with anti drug antibodies.

  6. Number of Episodes of Total Hypoglycemia Episodes

    Time frame: Baseline through 3 Months

    Number of episodes of total hypoglycemia episodes with plasma glucose <= ( less than or equal to) 54 mg/dL.

  7. Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide

    Time frame: Week 4, 8 12: Pre-dose

    Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2, Double-Blind, Placebo-Controlled, 3-Month Trial of LY3298176 Versus Placebo in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2017
Registry last updated
May 19, 2021

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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