Status:
COMPLETED
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2018
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT03311724
Start Date
October 19 2017
End Date
April 24 2018
Last Update
May 19 2021
Active Locations (13)
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1
Valley Research
Fresno, California, United States, 93720
2
National Research Institute
Los Angeles, California, United States, 90057
3
Catalina Research Institute, LLC
Montclair, California, United States, 91763
4
University Clinical Investigators, Inc.
Tustin, California, United States, 92780