Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT03060980
- Lead Sponsor
- Intarcia Therapeutics
- Brief Summary
A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 245
- Diagnosis of T2D 3 months prior to the Screening Visit.
- 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).
- History of type 1 diabetes.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Group 1 ITCA 650 20/60 mcg/day ITCA 650 20/60 mcg/day Experimental: Group 2 Empagliflozin (oral) Empagliflozin 10 mg/day and 25 mg/day Experimental: Group 3 Glimepiride (oral) Glimepiride 1-6 mg/day
- Primary Outcome Measures
Name Time Method Reduction in glycosylated hemoglobin A1c Randomization to 69 weeks To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Reduction in weight Randomization to 69 weeks To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (92)
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
Canyon Medical Center, LLC
🇺🇸Columbus, Ohio, United States
Medication Management, LLC
🇺🇸Greensboro, North Carolina, United States
Clinical Research Institute of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Research Institute of Dallas
🇺🇸Dallas, Texas, United States
CookMed Research
🇨🇦Victoria, British Columbia, Canada
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Catalina Research Institute
🇺🇸Montclair, California, United States
Colorado Springs Health Partners - East
🇺🇸Colorado Springs, Colorado, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Andres Patron, D.O., P.A
🇺🇸Pembroke Pines, Florida, United States
Harleysville Medical Associates
🇺🇸Harleysville, Pennsylvania, United States
Clinical Research Advantage
🇺🇸Evansville, Indiana, United States
HealthCare Research Network
🇺🇸Hazelwood, Missouri, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Skyline Medical Center
🇺🇸Elkhorn, Nebraska, United States
Nature Coast Clinical Reseaerch - Crystal River
🇺🇸Crystal River, Florida, United States
Radiant Research, Inc.
🇺🇸Edina, Minnesota, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
Medical and Procedural Specialists
🇺🇸Skokie, Illinois, United States
Columbine Family Practice
🇺🇸Littleton, Colorado, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Nevada Family Care
🇺🇸Henderson, Nevada, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Oklahoma City Clinic - Midwest City
🇺🇸Midwest City, Oklahoma, United States
Wells Institute for Health Awareness
🇺🇸Kettering, Ohio, United States
University of Toledo
🇺🇸Toledo, Ohio, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Michigan Avenue Internists
🇺🇸Chicago, Illinois, United States
Preferred Primary Care Phys Inc
🇺🇸Pittsburgh, Pennsylvania, United States
Ericksen Research and Development, LLC
🇺🇸Clinton, Utah, United States
Milestone Research
🇨🇦London, Ontario, Canada
Bluewater Clinical Research Group
🇨🇦Sarnia, Ontario, Canada
Sound Healthcare
🇺🇸Port Orchard, Washington, United States
Marin Endocrine Care and Research, Inc.
🇺🇸Greenbrae, California, United States
Research Center of Fresno, Inc.
🇺🇸Fresno, California, United States
Palm Harbor Medical Associates
🇺🇸Palm Harbor, Florida, United States
Indago Research and Health Center, Inc.
🇺🇸Hialeah, Florida, United States
South Broward Research
🇺🇸Pembroke Pines, Florida, United States
Primary Care Research Group
🇺🇸Atlanta, Georgia, United States
HSHS Medical Group DIabetes Research
🇺🇸Springfield, Illinois, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Community Hospital of Anderson and Madison County, Inc.
🇺🇸Anderson, Indiana, United States
Overland Park Surgical Specialists, LLL dba College Park Family Care Center
🇺🇸Overland Park, Kansas, United States
Ehrhardt Clinical Research, LLC
🇺🇸Belton, Missouri, United States
Scott Research Center
🇺🇸Laurelton, New York, United States
Down East Medical Associates, PA
🇺🇸Morehead City, North Carolina, United States
Intend Research
🇺🇸Norman, Oklahoma, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Global Medical Research
🇺🇸DeSoto, Texas, United States
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
Sante Clinical Research
🇺🇸Kerrville, Texas, United States
Health Texas Research Institute
🇺🇸San Angelo, Texas, United States
Dr. Anil K. Gupta Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
PCP for Life - -Tidwell
🇺🇸Houston, Texas, United States
Research Institure of South Florida
🇺🇸Miami, Florida, United States
Palm Research Center, Inc.
🇺🇸Las Vegas, Nevada, United States
Sentral Clinical Research Services, LLC
🇺🇸Cincinnati, Ohio, 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
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Family Practice Specialists
🇺🇸Phoenix, Arizona, United States
Central Phoenix Medical Center
🇺🇸Phoenix, Arizona, United States
Thomas C. Lenzmeier, M.D., P.C.
🇺🇸Glendale, Arizona, United States
Fiel Family and Sports Medicine
🇺🇸Tempe, Arizona, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Arizona Community Physicians
🇺🇸Tucson, Arizona, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Holston Medical Group, P.C.
🇺🇸Kingsport, Tennessee, United States
Orange Grove Family Practice
🇺🇸Tucson, Arizona, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Albany Medical College
🇺🇸Albany, New York, United States
Clinical Research of Rock Hill
🇺🇸Rock Hill, South Carolina, United States
Bailey Clinic
🇨🇦Red Deer, Alberta, Canada
Fountain Hills Family Practice, P.C.
🇺🇸Fountain Hills, Arizona, United States
Oklahoma City Clinic - Central
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
American Health Network of Indiana, LLC
🇺🇸New Albany, Indiana, United States
American Health Research
🇺🇸Charlotte, North Carolina, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
Panacea Clinical Research
🇺🇸San Antonio, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Crossroads Clinical Research, LLC
🇺🇸Victoria, Texas, United States
Center for Clinical Trials of Sacramento, Inc.
🇺🇸Sacramento, California, United States
Denver VA Medical Center
🇺🇸Aurora, Colorado, United States
DCT-AACT, LLC dba Discovery Clinical Trials
🇺🇸Austin, Texas, United States
Radiant Research
🇺🇸Murray, Utah, United States