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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311724
• Other study ID #: 16860
• Secondary ID: I8F-MC-GPGF
• Status: Completed
• Phase: Phase 2
• Start date: October 19, 2017
• Est. completion date: April 24, 2018

Study information

• Verified date: April 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 24, 2018
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Haemoglobin A1c (HbA1c)	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.	Baseline, 3 Months
Secondary	Percentage of Participants Achieving HbA1c Target of <7.0%	Percentage of participants achieving HbA1c target of < (less than) 7.0%.	3 Months
Secondary	Change From Baseline in Fasting Blood Glucose (FBG)	LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.	Baseline, 3 Months
Secondary	Change From Baseline in Body Weight	LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.	Baseline, 3 Months
Secondary	Change From Baseline in Waist Circumference	LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment*time as fixed factors.	Baseline, 3 Months
Secondary	Number of Participants With Anti Drug Antibodies	Number of participants with anti drug antibodies.	Baseline through 3 Months
Secondary	Number of Episodes of Total Hypoglycemia Episodes	Number of episodes of total hypoglycemia episodes with plasma glucose <= ( less than or equal to) 54 mg/dL.	Baseline through 3 Months
Secondary	Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide	Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide.	Week 4, 8 12: Pre-dose

External Links

•   A Study of Tirzepatide in Participants With Type 2 Diabetes