A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
1 other identifier
interventional
105
1 country
67
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus-type-2
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedOctober 11, 2012
October 1, 2012
2.3 years
September 12, 2005
October 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Fasting Blood Glucose at 8 weeks
Secondary Outcomes (1)
Pharmacodynamic parameters at all time points
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Apex Clinical Trials, Inc.
Birmingham, Alabama, 35209, United States
Greystone Medical Research, LLC
Birmingham, Alabama, 35242, United States
Med Search, LLC
Calera, Alabama, 35040, United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
Clinic of Physicians and Surgeons
Mesa, Arizona, 85201, United States
Horizon Clinical Research Associates
Mesa, Arizona, 85206, United States
Cochise Clinical Research
Sierra Vista, Arizona, 85635, United States
Sagebrush Medical Plaza, Department of Family Medicine
Bakersfield, California, 93305, United States
Family Medical Center
Foothill Ranch, California, 92610, United States
Prime-Care Clinical Research
Mission Viejo, California, 92691, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Orange County Research Center
Tustin, California, 92780, United States
Quality Care Medical Center
Vista, California, 92084, United States
Arapahoe Internal Medicine
Littleton, Colorado, 80120, United States
Institute Diabetes and Metabolic Disease
Newark, Delaware, 19713, United States
Alliance Medical Reserach Group, Inc.
Clearwater, Florida, 33755, United States
Personal Physician Care
Delray Beach, Florida, 33445, United States
Century Clinical Research, Inc
Holly Hill, Florida, 32117, United States
Innovative Research of West Florida
Largo, Florida, 33770, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, 34239, United States
Executive Health and Research Associates, Inc.
Atlanta, Georgia, 30342, United States
Capital City Family Medicine
Boise, Idaho, 83702, United States
Orthopedic Health Care Clinic
Boise, Idaho, 83702, United States
Sonora Clinical Research
Boise, Idaho, 83702, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Chicago Research Center, Inc.
Chicago, Illinois, 60634, United States
Heart of America Research
Shawnee, Kansas, 66216, United States
Dolby Research, LLC
Baton Rouge, Louisiana, 70809, United States
Acadia Clinical Research, LLC
Bangor, Maine, 04401, United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Professional Clinical Reserach -Great Lakes Family Care
Cadillac, Michigan, 49601, United States
Synergy Medical Education Alliance
Saginaw, Michigan, 48602, United States
Medex Healthcare Research, Inc
St Louis, Missouri, 63108, United States
Mercury Street Medical
Butte, Montana, 59701, United States
Specialty Medical Center
Pahrump, Nevada, 89048, United States
Bassett Healthcare
Cooperstown, New York, 13326, United States
DiGiovanna Family Care Center
Great Neck, New York, 11021, United States
United Physicians Group - Endocrine Division
Great Neck, New York, 11021, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45252, United States
Wells Institute for Health Awareness
Kettering, Ohio, 45429, United States
Fallen Timbers Internal Medicine LLC
Maumee, Ohio, 43537, United States
COR Clinical Reserch, LLC
Oklahoma City, Oklahoma, 73103, United States
Cllinical Research Consultants
Medford, Oregon, 97504, United States
Covance Clinical Research Unit, Inc
Portland, Oregon, 92739, United States
Michael A. Azorr, M.D.
Portland, Oregon, 97232, United States
Keystone Clinical Solutions
Altoona, Pennsylvania, 16602, United States
Southeastern PA Medical Institute
Havertown, Pennsylvania, 19083, United States
Greenand Seidner Family Practice
Lansdale, Pennsylvania, 19446, United States
Thomas Jefferson University Div of Endocrinology
Philadelphia, Pennsylvania, 19107, United States
Founders Medical Practice
Philadelphia, Pennsylvania, 19152, United States
Research Endeavors
Pittsburgh, Pennsylvania, 15238, United States
Hillcrest Clinical Research LLC
Simpsonville, South Carolina, 29681, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
John Joseph, MD PA
Carrollton, Texas, 75007, United States
Renaissance Clinical Research
Dallas, Texas, 75235, United States
MCA Research
Houston, Texas, 77024, United States
Southwest Houston Research, LTD
Houston, Texas, 77074, United States
Professional for Clinical Research
Plano, Texas, 75093, United States
Research Across America
Plano, Texas, 75093, United States
Benjamin Garwood Research
San Antonio, Texas, 78216, United States
WellMed at Northern Hills
San Antonio, Texas, 78217, United States
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78229, United States
Diabetes and Glandular Disease - Westside office
San Antonio, Texas, 78237, United States
Liberty Research Center
Tacoma, Washington, 98405, United States
Hyperion Clinical Trials, Inc.
Charleston, West Virginia, 25304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joseph G Bisaha, Ph.D.
Ono Pharma USA Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 21, 2005
Study Start
June 1, 2005
Primary Completion
October 1, 2007
Last Updated
October 11, 2012
Record last verified: 2012-10