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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03311724
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tirzepatide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Placebo-Controlled, 3-Month Trial of LY3298176 Versus Placebo in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : October 19, 2017
Actual Primary Completion Date : April 24, 2018
Actual Study Completion Date : April 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tirzepatide Group 1
Tirzepatide administered subcutaneously (SC)
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: Tirzepatide Group 2
Tirzepatide administered SC
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: Tirzepatide Group 3
Tirzepatide administered SC
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Placebo Comparator: Placebo
Placebo administered SC
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 3 Months ]
    Change from baseline in HbA1c


Secondary Outcome Measures :
  1. Proportion of Participants Achieving HbA1c Target of <7.0% [ Time Frame: 3 Months ]
    Proportion of participants achieving HbA1c target of <7.0%

  2. Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, 3 Months ]
    Change from baseline in FBG

  3. Change from Baseline in Body Weight [ Time Frame: Baseline, 3 Months ]
    Change from baseline in body weight

  4. Change from Baseline in Waist Circumference [ Time Frame: Baseline, 3 Months ]
    Change from baseline in waist circumference

  5. Number of Participants with Anti-Tirzepatide Antibodies [ Time Frame: Baseline through 3 Months ]
    Number of participants with anti-Tirzepatide antibodies

  6. Rate of Total Hypoglycemia [ Time Frame: Baseline through 3 Months ]
    Rate of total hypoglycemia

  7. Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide [ Time Frame: Predose Month 1 through 3 Months ]
    PK: Conctrough of Tirzepatide



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311724


Locations
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United States, California
Valley Research
Fresno, California, United States, 93720
National Research Institute
Los Angeles, California, United States, 90057
Catalina Research Institute, LLC
Montclair, California, United States, 91763
University Clinical Investigators, Inc.
Tustin, California, United States, 92780
United States, Connecticut
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
Suncoast Research Group, LLC
Miami, Florida, United States, 33135
United States, Idaho
Solaris Clinical Research
Meridian, Idaho, United States, 83646
United States, Kansas
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States, 66606
United States, Missouri
Clinical Research Professionals
Saint Louis, Missouri, United States, 63141
United States, Ohio
Aventiv Research
Columbus, Ohio, United States, 43213
United States, Tennessee
New Phase Research & Development
Knoxville, Tennessee, United States, 37909
United States, Texas
Dallas Diabetes Endocrine Center
Dallas, Texas, United States, 75230
Consano Clinical Research
Shavano Park, Texas, United States, 78231
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03311724     History of Changes
Other Study ID Numbers: 16860
I8F-MC-GPGF ( Other Identifier: Eli Lilly and Company )
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases