A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:April 2014
End Date:October 2015

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Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes

The main purpose of this study is to compare the safety and effectiveness of the study drug
known as LY2944876 to exenatide extended-release and placebo in participants with type 2
diabetes mellitus. All drugs will be given by an injection under the skin. Participants
remain on stable doses of metformin, as prescribed by their personal investigator if they
were on metformin at study entry. Participants involvement in the study is expected to last
about 30 weeks.

The study will include a 12 week blinded treatment period, where neither the participant nor
the investigator will know to which treatment each individual is assigned. Thereafter
follows a 12 week period where participants and the investigator will know which treatment
they are assigned to. Participants on LY2944876 and on exenatide extended-release continue
treatment in this period, those who received placebo will be followed without treatment.

Inclusion Criteria:

- Men or women with diabetes mellitus Type 2

- Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a
stable dose of metformin (≥1000 mg/day) for 3 months prior to screening

- Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening

Exclusion Criteria:

- Women of child bearing potential

- Participants who have used thiazolidinediones within 3 months prior to screening, or
any other drugs for treatment of hyperglycemia (except metformin) within the prior 2
months

- Participants who have used insulin for diabetic control for more than 6 consecutive
days within the prior year

- Participants with impaired renal function (serum creatinine >124 micromole per liter
(µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in
men)
We found this trial at
32
sites
Springfield, Missouri 65807
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2500 Campus Rd
Honolulu, Hawaii 96822
(808) 956-8111
Univ of Hawaii Honolulu Community College is an integral part of the University of Hawai?i,...
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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Los Angeles, CA
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2128 W Flagler St # 201
Miami, Florida 33144
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Altoona, Pennsylvania 16602
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Altoona, PA
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Ampelokipoi,
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Austin, TX
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Bountiful, Utah 84010
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Bradenton, Florida
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Concord, CA
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Corvallis, Oregon 97330
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Dallas, TX
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Des Moines, Iowa 50314
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Fargo, North Dakota 58103
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Fort Lauderdale, Florida 33316
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Fresno, California 93720
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Georgetown, Texas 78626
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High Point, North Carolina 27265
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Honolulu, Hawaii 96814
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Idaho Falls, ID
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Nashua, NH
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New Port Richey, Florida 34652
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Oviedo, Florida 32765
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Palm Springs, California 92262
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San Antonio, Texas 78128
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San Diego, California 92123
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Spring Valley, California 91978
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St Louis, Missouri 63141
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Sugar Land, Texas 77478
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Topeka, KS
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Washington, Missouri 63090
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Winter Haven, Florida 33880
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