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
Palm Springs, California 92262
1080
mi
from
Palm Springs, CA
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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,...
3715
mi
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Honolulu, HI
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
1170
mi
from
Los Angeles, CA
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2128 W Flagler St # 201
Miami, Florida 33144
1319
mi
from
Miami, FL
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Altoona, Pennsylvania 16602
1055
mi
from
Altoona, PA
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?
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Ampelokipoi,
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511
mi
from
Austin, TX
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Bountiful, Utah 84010
780
mi
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Bountiful, UT
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Bradenton, Florida
1132
mi
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Bradenton, FL
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1316
mi
from
Concord, CA
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Corvallis, Oregon 97330
1398
mi
from
Corvallis, OR
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340
mi
from
Dallas, TX
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Des Moines, Iowa 50314
347
mi
from
Des Moines, IA
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Fargo, North Dakota 58103
631
mi
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Fargo, ND
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Fort Lauderdale, Florida 33316
1307
mi
from
Fort Lauderdale, FL
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Fresno, California 93720
1205
mi
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Fresno, CA
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Georgetown, Texas 78626
491
mi
from
Georgetown, TX
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High Point, North Carolina 27265
991
mi
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High Point, NC
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Honolulu, Hawaii 96814
3717
mi
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Honolulu, HI
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843
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Idaho Falls, ID
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1423
mi
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Nashua, NH
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New Port Richey, Florida 34652
1091
mi
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New Port Richey, FL
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Oviedo, Florida 32765
1144
mi
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Oviedo, FL
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San Antonio, Texas 78128
576
mi
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San Antonio, TX
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San Diego, California 92123
1139
mi
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San Diego, CA
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Spring Valley, California 91978
1133
mi
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Spring Valley, CA
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Springfield, Missouri 65807
251
mi
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Springfield, MO
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St Louis, Missouri 63141
404
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St Louis, MO
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Sugar Land, Texas 77478
576
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Sugar Land, TX
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146
mi
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Topeka, KS
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Washington, Missouri 63090
374
mi
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Washington, MO
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Winter Haven, Florida 33880
1148
mi
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Winter Haven, FL
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