A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
NCT ID: NCT02119819
Last Updated: 2021-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
420 participants
INTERVENTIONAL
2014-04-30
2015-10-31
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
TREATMENT
DOUBLE
Study Groups
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10 mg LY2944876
10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.
Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
LY2944876
Administered SC
Metformin
Oral
15 mg LY2944876
15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
LY2944876
Administered SC
Metformin
Oral
30 mg LY2944876
30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
LY2944876
Administered SC
Metformin
Oral
50 mg LY2944876
50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
LY2944876
Administered SC
Metformin
Oral
Exenatide extended-release
2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
Exenatide extended-release
Administered SC
Metformin
Oral
Placebo
Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.
Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.
Placebo
Administered SC
Metformin
Oral
Interventions
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LY2944876
Administered SC
Exenatide extended-release
Administered SC
Placebo
Administered SC
Metformin
Oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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OPKO Health, Inc.
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 Physician Network Clinical Research Center
Concord, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
National Research Institute
Los Angeles, California, United States
Desert Medical Group Inc
Palm Springs, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Meridien Research
Bradenton, Florida, United States
M & O Clinical Research, LLC
Fort Lauderdale, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Compass Research
Oviedo, Florida, United States
Clinical Research of Central Florida
Winter Haven, 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
Iderc, P.L.C.
Des Moines, Iowa, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
St John's Mercy Medical Center
St Louis, Missouri, United States
Mercy Health Research
Washington, Missouri, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
High Point Clinical Trials Center
High Point, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, United States
Blair Medical Associates, Inc.
Altoona, Pennsylvania, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
San Gabriel Clinical Research
Georgetown, Texas, United States
Oakwell Clinical Research
San Antonio, Texas, United States
Southwest Health Associates, P.A.
Sugar Land, Texas, United States
Wade Family Medicine
Bountiful, Utah, 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.
Ampelokipoi, , 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.
Athens, , Greece
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Thessaloniki, , Greece
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Tampico, , Mexico
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Bialystok, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Lodz, , Poland
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Poznan, , Poland
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.
Szczecin, , Poland
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Warsaw, , Poland
Manati Medical Center
Manatí, , Puerto Rico
American Telemedicine Center
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.
Cluj-Napoca, , Romania
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.
Iași, , Romania
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.
Ploieşti, , Romania
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Târgu Mureş, , Romania
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.
Timișoara, , Romania
Countries
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References
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Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Other Identifiers
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2013-003552-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
I7I-MC-XNAA
Identifier Type: OTHER
Identifier Source: secondary_id
15062
Identifier Type: -
Identifier Source: org_study_id
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