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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:11/21/2018
Start Date:October 19, 2017
End Date:April 24, 2018

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

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


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 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.
We found this trial at
13
sites
1040 North Mason Road
Saint Louis, Missouri 63141
Principal Investigator: Timothy Jennings
Phone: 636-220-1200
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
Principal Investigator: Juan Frias
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Los Angeles, CA
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2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: Mark Kutner
Phone: 305-631-6704
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Miami, FL
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Principal Investigator: Joseph Soufer
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Waterbury, CT
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Columbus, Ohio 43213
Principal Investigator: Samir Arora
Phone: 614-501-6164
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Columbus, OH
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Dallas, Texas 75230
Principal Investigator: Julio Rosenstock
Phone: 972-566-7799
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Dallas, TX
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Fresno, California 93720
Principal Investigator: Paul Norwood
Phone: 559-261-0992
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Fresno, CA
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Knoxville, Tennessee 37923
Principal Investigator: Evelyne Davidson
Phone: 865-200-8364
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Knoxville, TN
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Meridian, Idaho 83646
Principal Investigator: David Butuk
Phone: 208-288-0123
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Meridian, ID
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Montclair, California 91763
Principal Investigator: Gilbert Martinez
Phone: 909-445-8451
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Montclair, CA
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Shavano Park, Texas 78231
Principal Investigator: Michelle Welch
Phone: 210-545-4900
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Shavano Park, TX
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Topeka, Kansas 66606
Principal Investigator: Alan Wynne
Phone: 785-368-0490
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Topeka, KS
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Tustin, California 92780
Principal Investigator: Joanna Van
Phone: 714-760-9317
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Tustin, CA
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