A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00212641
- Lead Sponsor
- Ono Pharma USA Inc
- Brief Summary
The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- Type 2 Diabetes Mellitus
- FBG level > 140 mg/dL and < 270 mg/dL
- Fasting TG level < 500 mg/dL
- BMI of 22 to 40 kg/m2, inclusive
- Other Inclusion criteria as specified in the study protocol
- Previous participation in an ONO-5129 protocol
- Previous treatment with TZD agents or other current antidiabetics
- History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months
- Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe)
- Other exclusion criteria as specified in the study protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Fasting Blood Glucose at 8 weeks
- Secondary Outcome Measures
Name Time Method Pharmacodynamic parameters at all time points
Trial Locations
- Locations (67)
Renaissance Clinical Research
🇺🇸Dallas, Texas, United States
Founders Medical Practice
🇺🇸Philadelphia, Pennsylvania, United States
Executive Health and Research Associates, Inc.
🇺🇸Atlanta, Georgia, United States
Acadia Clinical Research, LLC
🇺🇸Bangor, Maine, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Cllinical Research Consultants
🇺🇸Medford, Oregon, United States
Capital City Family Medicine
🇺🇸Boise, Idaho, United States
Quality Care Medical Center
🇺🇸Vista, California, United States
Orthopedic Health Care Clinic
🇺🇸Boise, Idaho, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Sonora Clinical Research
🇺🇸Boise, Idaho, United States
Clinic of Physicians and Surgeons
🇺🇸Mesa, Arizona, United States
Alliance Medical Reserach Group, Inc.
🇺🇸Clearwater, Florida, United States
Century Clinical Research, Inc
🇺🇸Holly Hill, Florida, United States
Innovative Research of West Florida
🇺🇸Largo, Florida, United States
Wells Institute for Health Awareness
🇺🇸Kettering, Ohio, United States
Fallen Timbers Internal Medicine LLC
🇺🇸Maumee, Ohio, United States
Family Medical Center
🇺🇸Foothill Ranch, California, United States
Prime-Care Clinical Research
🇺🇸Mission Viejo, California, United States
Institute Diabetes and Metabolic Disease
🇺🇸Newark, Delaware, United States
Arapahoe Internal Medicine
🇺🇸Littleton, Colorado, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Horizon Clinical Research Associates
🇺🇸Mesa, Arizona, United States
Sagebrush Medical Plaza, Department of Family Medicine
🇺🇸Bakersfield, California, United States
Professional for Clinical Research
🇺🇸Plano, Texas, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Dolby Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
Cochise Clinical Research
🇺🇸Sierra Vista, Arizona, United States
Professional Clinical Reserach -Great Lakes Family Care
🇺🇸Cadillac, Michigan, United States
John Joseph, MD PA
🇺🇸Carrollton, Texas, United States
Medex Healthcare Research, Inc
🇺🇸Saint Louis, Missouri, United States
Mercury Street Medical
🇺🇸Butte, Montana, United States
United Physicians Group - Endocrine Division
🇺🇸Great Neck, New York, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Liberty Research Center
🇺🇸Tacoma, Washington, United States
Hyperion Clinical Trials, Inc.
🇺🇸Charleston, West Virginia, United States
Specialty Medical Center
🇺🇸Pahrump, Nevada, United States
Research Across America
🇺🇸Plano, Texas, United States
Thomas Jefferson University Div of Endocrinology
🇺🇸Philadelphia, Pennsylvania, United States
Greenand Seidner Family Practice
🇺🇸Lansdale, Pennsylvania, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Chicago Research Center, Inc.
🇺🇸Chicago, Illinois, United States
MCA Research
🇺🇸Houston, Texas, United States
Southwest Houston Research, LTD
🇺🇸Houston, Texas, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Apex Clinical Trials, Inc.
🇺🇸Birmingham, Alabama, United States
Greystone Medical Research, LLC
🇺🇸Birmingham, Alabama, United States
COR Clinical Reserch, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Covance Clinical Research Unit, Inc
🇺🇸Portland, Oregon, United States
Michael A. Azorr, M.D.
🇺🇸Portland, Oregon, United States
Research Endeavors
🇺🇸Pittsburg, Pennsylvania, United States
Benjamin Garwood Research
🇺🇸San Antonio, Texas, United States
WellMed at Northern Hills
🇺🇸San Antonio, Texas, United States
Diabetes and Glandular Disease Research Associates
🇺🇸San Antonio, Texas, United States
Diabetes and Glandular Disease - Westside office
🇺🇸San Antonio, Texas, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Med Search, LLC
🇺🇸Calera, Alabama, United States
Personal Physician Care
🇺🇸Delray Beach, Florida, United States
Cardiovascular Center of Sarasota
🇺🇸Sarasota, Florida, United States
Heart of America Research
🇺🇸Shawnee, Kansas, United States
DiGiovanna Family Care Center
🇺🇸Great Neck, New York, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Synergy Medical Education Alliance
🇺🇸Saginaw, Michigan, United States
Bassett Healthcare
🇺🇸Cooperstown, New York, United States
Southeastern PA Medical Institute
🇺🇸Havertown, Pennsylvania, United States
Keystone Clinical Solutions
🇺🇸Altoona, Pennsylvania, United States
Hillcrest Clinical Research LLC
🇺🇸Simpsonville, South Carolina, United States