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
Meridian, Idaho 83646
Principal Investigator: David Butuk
Phone: 208-288-0123
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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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Montclair, California 91763
Principal Investigator: Gilbert Martinez
Phone: 909-445-8451
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Montclair, CA
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1040 North Mason Road
Saint Louis, Missouri 63141
Principal Investigator: Timothy Jennings
Phone: 636-220-1200
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Saint Louis, MO
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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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