A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus
NCT ID: NCT02111096
Last Updated: 2019-10-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
174 participants
INTERVENTIONAL
2014-04-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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LY2409021
20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
LY2409021
Administered orally
Metformin
Administered orally
Sulfonylurea
Administered orally
Sitagliptin
100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
Sitagliptin
Administered orally
Metformin
Administered orally
Sulfonylurea
Administered orally
Placebo
Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
Placebo
Administered orally
Metformin
Administered orally
Sulfonylurea
Administered orally
Interventions
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LY2409021
Administered orally
Sitagliptin
Administered orally
Placebo
Administered orally
Metformin
Administered orally
Sulfonylurea
Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
79 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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John Muir Health Network - The Osteoporosis Center
Concord, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
National Research Institute
Los Angeles, California, United States
Suncoast Research Group, LLC
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
University of Hawaii
Honolulu, Hawaii, United States
East West Medical Institute
Honolulu, Hawaii, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Midwest CRC
Crystal Lake, Illinois, United States
Iderc, P.L.C.
Des Moines, Iowa, United States
Cotton O'Neil Clinic
Topeka, Kansas, United States
Centex Studies, Inc
Lake Charles, Louisiana, United States
Cosmopolitan International Diabetes Center
Columbia, Missouri, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
Palm Research Center
Las Vegas, Nevada, United States
SHS Clinical Research Group
Toms River, New Jersey, United States
Office:Alwine,Lk
Downingtown, Pennsylvania, United States
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
Galenos Research
Dallas, Texas, United States
San Gabriel Clinical Research
Georgetown, Texas, United States
Oakwell Clinical Research
San Antonio, Texas, United States
Victorium Clinical Research
San Antonio, Texas, United States
Polyclinic
Seattle, Washington, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Athens, , Greece
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Thessaloniki, , Greece
PRADNET, Inc. Centro Especializado de Nutricion y Bariatria
Hato Rey, , Puerto Rico
American Telemedicine Center
San Juan, , Puerto Rico
GCM Medical Group PSC
San Juan, , Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Changhua, , Taiwan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Yong Kung City, , Taiwan
Countries
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References
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Kazda CM, Frias J, Foga I, Cui X, Guzman CB, Garhyan P, Heilmann C, Yang JA, Hardy TA. Treatment with the glucagon receptor antagonist LY2409021 increases ambulatory blood pressure in patients with type 2 diabetes. Diabetes Obes Metab. 2017 Aug;19(8):1071-1077. doi: 10.1111/dom.12904. Epub 2017 Mar 27.
Other Identifiers
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I1R-MC-GLDJ
Identifier Type: OTHER
Identifier Source: secondary_id
2013-004275-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15286
Identifier Type: -
Identifier Source: org_study_id
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