Clinical trial NCT03311724: A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Official title: A Phase 2, Double-Blind, Placebo-Controlled, 3-Month Trial of LY3298176 Versus Placebo in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-10-17
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Haemoglobin A1c (HbA1c)
timeFrame: Baseline, 3 Months
Secondary outcomes:
measure: Percentage of Participants Achieving HbA1c Target of <7.0%
timeFrame: 3 Months
measure: Change From Baseline in Fasting Blood Glucose (FBG)
timeFrame: Baseline, 3 Months
measure: Change From Baseline in Body Weight
timeFrame: Baseline, 3 Months
measure: Change From Baseline in Waist Circumference
timeFrame: Baseline, 3 Months
measure: Number of Participants With Anti Drug Antibodies
timeFrame: Baseline through 3 Months
measure: Number of Episodes of Total Hypoglycemia Episodes
timeFrame: Baseline through 3 Months
measure: Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide
timeFrame: Week 4, 8 12: Pre-dose
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Valley Research
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes and Endocrinology Center
state: Kansas
city: Saint Louis
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Knoxville
country: United States
facility: New Phase Research & Development
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes Endocrine Center
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: