Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin
NCT ID: NCT03060980
Last Updated: 2019-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
245 participants
INTERVENTIONAL
2017-03-03
2018-01-26
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
NONE
Study Groups
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Experimental: Group 1
ITCA 650 20/60 mcg/day
ITCA 650 20/60 mcg/day
ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
Experimental: Group 2
Empagliflozin 10 mg/day and 25 mg/day
Empagliflozin (oral)
10 mg/day and 25 mg/day
Experimental: Group 3
Glimepiride 1-6 mg/day
Glimepiride (oral)
1-6 mg/day
Interventions
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ITCA 650 20/60 mcg/day
ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
Empagliflozin (oral)
10 mg/day and 25 mg/day
Glimepiride (oral)
1-6 mg/day
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.
* Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).
Exclusion Criteria
* Prior participation in a clinical study involving ITCA 650.
* Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening.
* History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
* History or evidence of acute or chronic pancreatitis.
* History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
* Treatment of medications that affect GI motility.
* History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients.
* Women that are pregnant, lactating, or planning to become pregnant.
* Chronic (\>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.
18 Years
80 Years
ALL
No
Sponsors
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Intarcia Therapeutics
INDUSTRY
Responsible Party
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Locations
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Fountain Hills Family Practice, P.C.
Fountain Hills, Arizona, United States
Thomas C. Lenzmeier, M.D., P.C.
Glendale, Arizona, United States
Family Practice Specialists
Phoenix, Arizona, United States
Central Phoenix Medical Center
Phoenix, Arizona, United States
Fiel Family and Sports Medicine
Tempe, Arizona, United States
Arizona Community Physicians
Tucson, Arizona, United States
Orange Grove Family Practice
Tucson, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
Radiant Research
Carlsbad, California, United States
Research Center of Fresno, Inc.
Fresno, California, United States
Marin Endocrine Care and Research, Inc.
Greenbrae, California, United States
National Research Institute
Huntington Park, California, United States
National Research Institute
Los Angeles, California, United States
Catalina Research Institute
Montclair, California, United States
Providence Clinical Research
North Hollywood, California, United States
Center for Clinical Trials of Sacramento, Inc.
Sacramento, California, United States
Denver VA Medical Center
Aurora, Colorado, United States
Radiant Research
Centennial, Colorado, United States
Colorado Springs Health Partners - East
Colorado Springs, Colorado, United States
Columbine Family Practice
Littleton, Colorado, United States
Nature Coast Clinical Reseaerch - Crystal River
Crystal River, Florida, United States
Indago Research and Health Center, Inc.
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Research Institure of South Florida
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, United States
Andres Patron, D.O., P.A
Pembroke Pines, Florida, United States
South Broward Research
Pembroke Pines, Florida, United States
Primary Care Research Group
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Michigan Avenue Internists
Chicago, Illinois, United States
Medical and Procedural Specialists
Skokie, Illinois, United States
HSHS Medical Group DIabetes Research
Springfield, Illinois, United States
Community Hospital of Anderson and Madison County, Inc.
Anderson, Indiana, United States
Clinical Research Advantage
Evansville, Indiana, United States
American Health Network of Indiana, LLC
Franklin, Indiana, United States
American Health Network of Indiana, LLC
New Albany, Indiana, United States
Heartland Research Associates, LLC
Augusta, Kansas, United States
Overland Park Surgical Specialists, LLL dba College Park Family Care Center
Overland Park, Kansas, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Maine Research Associates
Auburn, Maine, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Radiant Research, Inc.
Edina, Minnesota, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, United States
HealthCare Research Network
Hazelwood, Missouri, United States
Mercury Street Medical Group
Butte, Montana, United States
Skyline Medical Center
Elkhorn, Nebraska, United States
Nevada Family Care
Henderson, Nevada, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Albany Medical College
Albany, New York, United States
Scott Research Center
Laurelton, New York, United States
American Health Research
Charlotte, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
Down East Medical Associates, PA
Morehead City, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Radiant Research
Akron, Ohio, United States
Sentral Clinical Research Services, LLC
Cincinnati, Ohio, United States
Canyon Medical Center, LLC
Columbus, Ohio, United States
Aventiv Research
Columbus, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Wells Institute for Health Awareness
Kettering, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Oklahoma City Clinic - Midwest City
Midwest City, Oklahoma, United States
Intend Research
Norman, Oklahoma, United States
Oklahoma City Clinic - Central
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, United States
Harleysville Medical Associates
Harleysville, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Preferred Primary Care Phys Inc
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Holston Medical Group, P.C.
Kingsport, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
DCT-AACT, LLC dba Discovery Clinical Trials
Austin, Texas, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Global Medical Research
DeSoto, Texas, United States
Juno Research
Houston, Texas, United States
PCP for Life - -Tidwell
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Health Texas Research Institute
San Angelo, Texas, United States
Panacea Clinical Research
San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Victorium Clinical Research Ltd.
San Antonio, Texas, United States
MacGregor Medical Center
San Antonio, Texas, United States
Crossroads Clinical Research, LLC
Victoria, Texas, United States
Ericksen Research and Development, LLC
Clinton, Utah, United States
Radiant Research
Murray, Utah, United States
Advanced Clinical Research
West Jordan, Utah, United States
Sound Healthcare
Port Orchard, Washington, United States
Bailey Clinic
Red Deer, Alberta, Canada
CookMed Research
Victoria, British Columbia, Canada
Milestone Research
London, Ontario, Canada
Bluewater Clinical Research Group
Sarnia, Ontario, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, Canada
Countries
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Other Identifiers
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ITCA 650-CLP-203
Identifier Type: -
Identifier Source: org_study_id
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