Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
| Verified date | October 2012 |
| Source | Ono Pharmaceutical Co. Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus
| Status | Completed |
| Enrollment | 105 |
| Est. completion date | |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: 1. Type 2 Diabetes Mellitus 2. FBG level > 140 mg/dL and < 270 mg/dL 3. Fasting TG level < 500 mg/dL 4. BMI of 22 to 40 kg/m2, inclusive 5. Other Inclusion criteria as specified in the study protocol Exclusion Criteria: 1. Previous participation in an ONO-5129 protocol 2. Previous treatment with TZD agents or other current antidiabetics 3. History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months 4. Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe) 5. Other exclusion criteria as specified in the study protocol |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Keystone Clinical Solutions | Altoona | Pennsylvania |
| United States | Executive Health and Research Associates, Inc. | Atlanta | Georgia |
| United States | Sagebrush Medical Plaza, Department of Family Medicine | Bakersfield | California |
| United States | Franklin Square Hospital Center | Baltimore | Maryland |
| United States | Acadia Clinical Research, LLC | Bangor | Maine |
| United States | Dolby Research, LLC | Baton Rouge | Louisiana |
| United States | Apex Clinical Trials, Inc. | Birmingham | Alabama |
| United States | Greystone Medical Research, LLC | Birmingham | Alabama |
| United States | Capital City Family Medicine | Boise | Idaho |
| United States | Orthopedic Health Care Clinic | Boise | Idaho |
| United States | Sonora Clinical Research | Boise | Idaho |
| United States | Mercury Street Medical | Butte | Montana |
| United States | Professional Clinical Reserach -Great Lakes Family Care | Cadillac | Michigan |
| United States | Med Search, LLC | Calera | Alabama |
| United States | John Joseph, MD PA | Carrollton | Texas |
| United States | Hyperion Clinical Trials, Inc. | Charleston | West Virginia |
| United States | Cedar-Crosse Research Center | Chicago | Illinois |
| United States | Chicago Research Center, Inc. | Chicago | Illinois |
| United States | New Horizons Clinical Research | Cincinnati | Ohio |
| United States | Alliance Medical Reserach Group, Inc. | Clearwater | Florida |
| United States | Bassett Healthcare | Cooperstown | New York |
| United States | Renaissance Clinical Research | Dallas | Texas |
| United States | Personal Physician Care | Delray Beach | Florida |
| United States | Centennial Medical Group | Elkridge | Maryland |
| United States | Family Medical Center | Foothill Ranch | California |
| United States | DiGiovanna Family Care Center | Great Neck | New York |
| United States | United Physicians Group - Endocrine Division | Great Neck | New York |
| United States | Southeastern PA Medical Institute | Havertown | Pennsylvania |
| United States | Century Clinical Research, Inc | Holly Hill | Florida |
| United States | MCA Research | Houston | Texas |
| United States | Southwest Houston Research, LTD | Houston | Texas |
| United States | Medical Affiliated Research Center | Huntsville | Alabama |
| United States | Wells Institute for Health Awareness | Kettering | Ohio |
| United States | Greenand Seidner Family Practice | Lansdale | Pennsylvania |
| United States | Innovative Research of West Florida | Largo | Florida |
| United States | Arapahoe Internal Medicine | Littleton | Colorado |
| United States | Fallen Timbers Internal Medicine LLC | Maumee | Ohio |
| United States | Cllinical Research Consultants | Medford | Oregon |
| United States | Clinic of Physicians and Surgeons | Mesa | Arizona |
| United States | Horizon Clinical Research Associates | Mesa | Arizona |
| United States | Winthrop University Hospital | Mineola | New York |
| United States | Prime-Care Clinical Research | Mission Viejo | California |
| United States | Institute Diabetes and Metabolic Disease | Newark | Delaware |
| United States | COR Clinical Reserch, LLC | Oklahoma City | Oklahoma |
| United States | Specialty Medical Center | Pahrump | Nevada |
| United States | Founders Medical Practice | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Div of Endocrinology | Philadelphia | Pennsylvania |
| United States | Research Endeavors | Pittsburg | Pennsylvania |
| United States | Professional for Clinical Research | Plano | Texas |
| United States | Research Across America | Plano | Texas |
| United States | Covance Clinical Research Unit, Inc | Portland | Oregon |
| United States | Michael A. Azorr, M.D. | Portland | Oregon |
| United States | Synergy Medical Education Alliance | Saginaw | Michigan |
| United States | Medex Healthcare Research, Inc | Saint Louis | Missouri |
| United States | Benjamin Garwood Research | San Antonio | Texas |
| United States | Diabetes and Glandular Disease - Westside office | San Antonio | Texas |
| United States | Diabetes and Glandular Disease Research Associates | San Antonio | Texas |
| United States | WellMed at Northern Hills | San Antonio | Texas |
| United States | Cardiovascular Center of Sarasota | Sarasota | Florida |
| United States | Heart of America Research | Shawnee | Kansas |
| United States | Cochise Clinical Research | Sierra Vista | Arizona |
| United States | Hillcrest Clinical Research LLC | Simpsonville | South Carolina |
| United States | Spartanburg Medical Research | Spartanburg | South Carolina |
| United States | Encompass Clinical Research | Spring Valley | California |
| United States | Liberty Research Center | Tacoma | Washington |
| United States | Orange County Research Center | Tustin | California |
| United States | Quality Care Medical Center | Vista | California |
| Lead Sponsor | Collaborator |
|---|---|
| Ono Pharma USA Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fasting Blood Glucose at 8 weeks | |||
| Secondary | Pharmacodynamic parameters at all time points |
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