A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus



Status:Terminated
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 79
Updated:4/26/2018
Start Date:April 2014
End Date:September 2015

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A Phase 2, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of LY2409021 Compared to Sitagliptin in Subjects With Type 2 Diabetes Mellitus

The intent of this study is to assess the safety of LY2409021 in participants with Type 2
diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal
physician. The study treatment is expected to last 12 months (52 weeks).


Inclusion Criteria:

- Have been treated with a stable dose of metformin for at least 3 months and have been
treated with an optimally effective and stable dose of an sulfonylurea for at least 6
months prior to screening.

- HbA1c value between 7.0% and 10.0%, inclusive.

- Body mass index (BMI) between 20 and 45 kilograms/square meter (kg/m^2), inclusive.

Exclusion Criteria:

- Known type 1 diabetes mellitus.

- More than 1 episode of severe hypoglycemia within 6 months prior to screening.

- Two or more emergency room visits or hospitalizations due to poor glucose control in
the 6 months prior to screening.

- Severe gastrointestinal disease that may significantly impact gastric emptying or
motility or having undergone gastric bypass or gastric banding surgery.

- Previous history or active diagnosis of pancreatitis.

- Positive hepatitis B surface antigen or hepatitis C antibody.

- Clinical signs or symptoms of liver disease, or hepatic aminotransferases
(aminotransferase or alanine aminotransferase) greater than 2.0× upper limit of normal
(ULN) or elevated alkaline phosphatase (greater than ULN) unrelated to bone metabolic
disease.

- Elevated total bilirubin level (greater than ULN), clinically suspicious
signs/symptoms of cirrhosis or history of cirrhosis.

- Current diagnosis, personal history of neuroendocrine tumors, family history of any
type of multiple endocrine neoplasia (MEN), or Von Hippel-Lindau.

- Contraindications for magnetic resonance imaging.
We found this trial at
27
sites
2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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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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2128 W Flagler St # 201
Miami, Florida 33144
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Miami, FL
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Athens,
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Chattanooga, Tennessee 37403
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Chicago, Illinois 60607
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Chicago, IL
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Columbia, MO
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Concord, CA
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Crystal Lake, Illinois 60012
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Dallas, TX
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Dallas, Texas 75251
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Des Moines, Iowa 50314
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Downingtown, Pennsylvania 19335
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Fresno, California 93720
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Georgetown, Texas 78626
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Honolulu, Hawaii 96814
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Idaho Falls, ID
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Lake Charles, Louisiana 70601
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Las Vegas, Nevada 89102
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Miami, Florida 33175
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San Antonio, Texas 78128
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San Antonio, Texas 78229
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Seattle, Washington 98122
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Seattle, WA
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Springfield, Missouri 65807
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5115 North Armenia Avenue
Tampa, Florida 33603
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Toms River, New Jersey
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Topeka, Kansas 66606
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