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

Phase 2

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered by SC injection.
2.5,5,10,15mg Tirzepatide	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.
4,8,12mg Tirzepatide	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.
2.5,7.5,15mg Tirzepatide	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Haemoglobin A1c (HbA1c)	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

Name	Time	Method
Change From Baseline in Waist Circumference	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.
Change From Baseline in Body Weight	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.
Number of Participants With Anti Drug Antibodies	Baseline through 3 Months	Number of participants with anti drug antibodies.
Percentage of Participants Achieving HbA1c Target of <7.0%	3 Months	Percentage of participants achieving HbA1c target of \< (less than) 7.0%.
Change From Baseline in Fasting Blood Glucose (FBG)	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.
Number of Episodes of Total Hypoglycemia Episodes	Baseline through 3 Months	Number of episodes of total hypoglycemia episodes with plasma glucose \<= ( less than or equal to) 54 mg/dL.
Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide	Week 4, 8 12: Pre-dose	Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide.

Locations (13): Valley Research
🇺🇸
Fresno, California, United States
National Research Institute
🇺🇸
Los Angeles, California, United States
University Clinical Investigators, Inc.
🇺🇸
Tustin, California, United States
Suncoast Research Group, LLC
🇺🇸
Miami, Florida, United States
Dallas Diabetes Endocrine Center
🇺🇸
Dallas, Texas, United States
Clinical Research Professionals
🇺🇸
Saint Louis, Missouri, United States
Aventiv Research
🇺🇸
Columbus, Ohio, United States
Catalina Research Institute, LLC
🇺🇸
Montclair, California, United States
Cotton O'Neil Diabetes and Endocrinology Center
🇺🇸
Topeka, Kansas, United States
Consano Clinical Research
🇺🇸
Shavano Park, Texas, United States
Chase Medical Research, LLC
🇺🇸
Waterbury, Connecticut, United States
New Phase Research & Development
🇺🇸
Knoxville, Tennessee, United States
Solaris Clinical Research
🇺🇸
Meridian, Idaho, United States