A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
Sponsor
Ono Pharma USA Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00212641
Collaborator
(none)
105
67
1.6
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
Study Start Date
:
Jun 1, 2005
Actual Primary Completion Date
:
Oct 1, 2007
Outcome Measures
Primary Outcome Measures
- Fasting Blood Glucose at 8 weeks []
Secondary Outcome Measures
- Pharmacodynamic parameters at all time points []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Apex Clinical Trials, Inc. | Birmingham | Alabama | United States | 35209 |
| 2 | Greystone Medical Research, LLC | Birmingham | Alabama | United States | 35242 |
| 3 | Med Search, LLC | Calera | Alabama | United States | 35040 |
| 4 | Medical Affiliated Research Center | Huntsville | Alabama | United States | 35801 |
| 5 | Clinic of Physicians and Surgeons | Mesa | Arizona | United States | 85201 |
| 6 | Horizon Clinical Research Associates | Mesa | Arizona | United States | 85206 |
| 7 | Cochise Clinical Research | Sierra Vista | Arizona | United States | 85635 |
| 8 | Sagebrush Medical Plaza, Department of Family Medicine | Bakersfield | California | United States | 93305 |
| 9 | Family Medical Center | Foothill Ranch | California | United States | 92610 |
| 10 | Prime-Care Clinical Research | Mission Viejo | California | United States | 92691 |
| 11 | Encompass Clinical Research | Spring Valley | California | United States | 91978 |
| 12 | Orange County Research Center | Tustin | California | United States | 92780 |
| 13 | Quality Care Medical Center | Vista | California | United States | 92084 |
| 14 | Arapahoe Internal Medicine | Littleton | Colorado | United States | 80120 |
| 15 | Institute Diabetes and Metabolic Disease | Newark | Delaware | United States | 19713 |
| 16 | Alliance Medical Reserach Group, Inc. | Clearwater | Florida | United States | 33755 |
| 17 | Personal Physician Care | Delray Beach | Florida | United States | 33445 |
| 18 | Century Clinical Research, Inc | Holly Hill | Florida | United States | 32117 |
| 19 | Innovative Research of West Florida | Largo | Florida | United States | 33770 |
| 20 | Cardiovascular Center of Sarasota | Sarasota | Florida | United States | 34239 |
| 21 | Executive Health and Research Associates, Inc. | Atlanta | Georgia | United States | 30342 |
| 22 | Capital City Family Medicine | Boise | Idaho | United States | 83702 |
| 23 | Orthopedic Health Care Clinic | Boise | Idaho | United States | 83702 |
| 24 | Sonora Clinical Research | Boise | Idaho | United States | 83702 |
| 25 | Cedar-Crosse Research Center | Chicago | Illinois | United States | 60607 |
| 26 | Chicago Research Center, Inc. | Chicago | Illinois | United States | 60634 |
| 27 | Heart of America Research | Shawnee | Kansas | United States | 66216 |
| 28 | Dolby Research, LLC | Baton Rouge | Louisiana | United States | 70809 |
| 29 | Acadia Clinical Research, LLC | Bangor | Maine | United States | 04401 |
| 30 | Franklin Square Hospital Center | Baltimore | Maryland | United States | 21237 |
| 31 | Centennial Medical Group | Elkridge | Maryland | United States | 21075 |
| 32 | Professional Clinical Reserach -Great Lakes Family Care | Cadillac | Michigan | United States | 49601 |
| 33 | Synergy Medical Education Alliance | Saginaw | Michigan | United States | 48602 |
| 34 | Medex Healthcare Research, Inc | Saint Louis | Missouri | United States | 63108 |
| 35 | Mercury Street Medical | Butte | Montana | United States | 59701 |
| 36 | Specialty Medical Center | Pahrump | Nevada | United States | 89048 |
| 37 | Bassett Healthcare | Cooperstown | New York | United States | 13326 |
| 38 | DiGiovanna Family Care Center | Great Neck | New York | United States | 11021 |
| 39 | United Physicians Group - Endocrine Division | Great Neck | New York | United States | 11021 |
| 40 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
| 41 | New Horizons Clinical Research | Cincinnati | Ohio | United States | 45252 |
| 42 | Wells Institute for Health Awareness | Kettering | Ohio | United States | 45429 |
| 43 | Fallen Timbers Internal Medicine LLC | Maumee | Ohio | United States | 43537 |
| 44 | COR Clinical Reserch, LLC | Oklahoma City | Oklahoma | United States | 73103 |
| 45 | Cllinical Research Consultants | Medford | Oregon | United States | 97504 |
| 46 | Covance Clinical Research Unit, Inc | Portland | Oregon | United States | 92739 |
| 47 | Michael A. Azorr, M.D. | Portland | Oregon | United States | 97232 |
| 48 | Keystone Clinical Solutions | Altoona | Pennsylvania | United States | 16602 |
| 49 | Southeastern PA Medical Institute | Havertown | Pennsylvania | United States | 19083 |
| 50 | Greenand Seidner Family Practice | Lansdale | Pennsylvania | United States | 19446 |
| 51 | Thomas Jefferson University Div of Endocrinology | Philadelphia | Pennsylvania | United States | 19107 |
| 52 | Founders Medical Practice | Philadelphia | Pennsylvania | United States | 19152 |
| 53 | Research Endeavors | Pittsburg | Pennsylvania | United States | 15238 |
| 54 | Hillcrest Clinical Research LLC | Simpsonville | South Carolina | United States | 29681 |
| 55 | Spartanburg Medical Research | Spartanburg | South Carolina | United States | 29303 |
| 56 | John Joseph, MD PA | Carrollton | Texas | United States | 75007 |
| 57 | Renaissance Clinical Research | Dallas | Texas | United States | 75235 |
| 58 | MCA Research | Houston | Texas | United States | 77024 |
| 59 | Southwest Houston Research, LTD | Houston | Texas | United States | 77074 |
| 60 | Professional for Clinical Research | Plano | Texas | United States | 75093 |
| 61 | Research Across America | Plano | Texas | United States | 75093 |
| 62 | Benjamin Garwood Research | San Antonio | Texas | United States | 78216 |
| 63 | WellMed at Northern Hills | San Antonio | Texas | United States | 78217 |
| 64 | Diabetes and Glandular Disease Research Associates | San Antonio | Texas | United States | 78229 |
| 65 | Diabetes and Glandular Disease - Westside office | San Antonio | Texas | United States | 78237 |
| 66 | Liberty Research Center | Tacoma | Washington | United States | 98405 |
| 67 | Hyperion Clinical Trials, Inc. | Charleston | West Virginia | United States | 25304 |
Sponsors and Collaborators
- Ono Pharma USA Inc
Investigators
- Study Director: Joseph G Bisaha, Ph.D., Ono Pharma USA Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ono Pharma USA Inc
ClinicalTrials.gov Identifier:
NCT00212641
Other Study ID Numbers:
- ONO-5129POU006
First Posted:
Sep 21, 2005
Last Update Posted:
Oct 11, 2012
Last Verified:
Oct 1, 2012