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A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT00212641
First received: September 12, 2005
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: ONO-5129
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Fasting Blood Glucose at 8 weeks

Secondary Outcome Measures:
  • Pharmacodynamic parameters at all time points

Estimated Enrollment: 105
Study Start Date: June 2005
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212641

  Hide Study Locations
Locations
United States, Alabama
Greystone Medical Research, LLC
Birmingham, Alabama, United States, 35242
Apex Clinical Trials, Inc.
Birmingham, Alabama, United States, 35209
Med Search, LLC
Calera, Alabama, United States, 35040
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
United States, Arizona
Clinic of Physicians and Surgeons
Mesa, Arizona, United States, 85201
Horizon Clinical Research Associates
Mesa, Arizona, United States, 85206
Cochise Clinical Research
Sierra Vista, Arizona, United States, 85635
United States, California
Sagebrush Medical Plaza, Department of Family Medicine
Bakersfield, California, United States, 93305
Family Medical Center
Foothill Ranch, California, United States, 92610
Prime-Care Clinical Research
Mission Viejo, California, United States, 92691
Encompass Clinical Research
Spring Valley, California, United States, 91978
Orange County Research Center
Tustin, California, United States, 92780
Quality Care Medical Center
Vista, California, United States, 92084
United States, Colorado
Arapahoe Internal Medicine
Littleton, Colorado, United States, 80120
United States, Delaware
Institute Diabetes and Metabolic Disease
Newark, Delaware, United States, 19713
United States, Florida
Alliance Medical Reserach Group, Inc.
Clearwater, Florida, United States, 33755
Personal Physician Care
Delray Beach, Florida, United States, 33445
Century Clinical Research, Inc
Holly Hill, Florida, United States, 32117
Innovative Research of West Florida
Largo, Florida, United States, 33770
Cardiovascular Center of Sarasota
Sarasota, Florida, United States, 34239
United States, Georgia
Executive Health and Research Associates, Inc.
Atlanta, Georgia, United States, 30342
United States, Idaho
Capital City Family Medicine
Boise, Idaho, United States, 83702
Sonora Clinical Research
Boise, Idaho, United States, 83702
Orthopedic Health Care Clinic
Boise, Idaho, United States, 83702
United States, Illinois
Cedar-Crosse Research Center
Chicago, Illinois, United States, 60607
Chicago Research Center, Inc.
Chicago, Illinois, United States, 60634
United States, Kansas
Heart of America Research
Shawnee, Kansas, United States, 66216
United States, Louisiana
Dolby Research, LLC
Baton Rouge, Louisiana, United States, 70809
United States, Maine
Acadia Clinical Research, LLC
Bangor, Maine, United States, 04401
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Centennial Medical Group
Elkridge, Maryland, United States, 21075
United States, Michigan
Professional Clinical Reserach -Great Lakes Family Care
Cadillac, Michigan, United States, 49601
Synergy Medical Education Alliance
Saginaw, Michigan, United States, 48602
United States, Missouri
Medex Healthcare Research, Inc
Saint Louis, Missouri, United States, 63108
United States, Montana
Mercury Street Medical
Butte, Montana, United States, 59701
United States, Nevada
Specialty Medical Center
Pahrump, Nevada, United States, 89048
United States, New York
Bassett Healthcare
Cooperstown, New York, United States, 13326
United Physicians Group - Endocrine Division
Great Neck, New York, United States, 11021
DiGiovanna Family Care Center
Great Neck, New York, United States, 11021
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, Ohio
New Horizons Clinical Research
Cincinnati, Ohio, United States, 45252
Wells Institute for Health Awareness
Kettering, Ohio, United States, 45429
Fallen Timbers Internal Medicine LLC
Maumee, Ohio, United States, 43537
United States, Oklahoma
COR Clinical Reserch, LLC
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Cllinical Research Consultants
Medford, Oregon, United States, 97504
Michael A. Azorr, M.D.
Portland, Oregon, United States, 97232
Covance Clinical Research Unit, Inc
Portland, Oregon, United States, 92739
United States, Pennsylvania
Keystone Clinical Solutions
Altoona, Pennsylvania, United States, 16602
Southeastern PA Medical Institute
Havertown, Pennsylvania, United States, 19083
Greenand Seidner Family Practice
Lansdale, Pennsylvania, United States, 19446
Founders Medical Practice
Philadelphia, Pennsylvania, United States, 19152
Thomas Jefferson University Div of Endocrinology
Philadelphia, Pennsylvania, United States, 19107
Research Endeavors
Pittsburg, Pennsylvania, United States, 15238
United States, South Carolina
Hillcrest Clinical Research LLC
Simpsonville, South Carolina, United States, 29681
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Texas
John Joseph, MD PA
Carrollton, Texas, United States, 75007
Renaissance Clinical Research
Dallas, Texas, United States, 75235
MCA Research
Houston, Texas, United States, 77024
Southwest Houston Research, LTD
Houston, Texas, United States, 77074
Research Across America
Plano, Texas, United States, 75093
Professional for Clinical Research
Plano, Texas, United States, 75093
Diabetes and Glandular Disease - Westside office
San Antonio, Texas, United States, 78237
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229
Benjamin Garwood Research
San Antonio, Texas, United States, 78216
WellMed at Northern Hills
San Antonio, Texas, United States, 78217
United States, Washington
Liberty Research Center
Tacoma, Washington, United States, 98405
United States, West Virginia
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
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT00212641     History of Changes
Other Study ID Numbers: ONO-5129POU006
Study First Received: September 12, 2005
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013