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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
Results First Posted : May 19, 2021
Last Update Posted : May 19, 2021
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: 4,8,12mg Tirzepatide
Participants received Tirzepatide by subcutaneous (SC) injection in three dose escalations starting with 4 milligrams (mg) for four weeks followed by 8mg for four weeks followed by 12mg for four weeks.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: 2.5,5,10,15mg Tirzepatide
Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: 2.5,7.5,15mg Tirzepatide
Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks.
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Placebo Comparator: Placebo
Placebo administered by SC injection.
Drug: Placebo
Administered SC




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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 (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.

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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] August 2, 2017
Statistical Analysis Plan  [PDF] May 1, 2018

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03311724    
Other Study ID Numbers: 16860
I8F-MC-GPGF ( Other Identifier: Eli Lilly and Company )
First Posted: October 17, 2017    Key Record Dates
Results First Posted: May 19, 2021
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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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
LY3298176
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists