Clinical trial NCT00212641: A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
Official title: Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Fasting Blood Glucose at 8 weeks
Secondary outcomes:
measure: Pharmacodynamic parameters at all time points
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Apex Clinical Trials, Inc.
state: Alabama
city: Birmingham
country: United States
facility: Greystone Medical Research, LLC
state: Alabama
city: Calera
country: United States
facility: Med Search, LLC
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Mesa
country: United States
facility: Clinic of Physicians and Surgeons
state: Arizona
city: Mesa
country: United States
facility: Horizon Clinical Research Associates
state: Arizona
city: Sierra Vista
country: United States
facility: Cochise Clinical Research
state: Arizona
city: Bakersfield
country: United States
facility: Sagebrush Medical Plaza, Department of Family Medicine
state: California
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Mission Viejo
country: United States
facility: Prime-Care Clinical Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Vista
country: United States
facility: Quality Care Medical Center
state: California
city: Littleton
country: United States
facility: Arapahoe Internal Medicine
state: Colorado
city: Newark
country: United States
facility: Institute Diabetes and Metabolic Disease
state: Delaware
city: Clearwater
country: United States
facility: Alliance Medical Reserach Group, Inc.
state: Florida
city: Delray Beach
country: United States
facility: Personal Physician Care
state: Florida
city: Holly Hill
country: United States
facility: Century Clinical Research, Inc
state: Florida
city: Largo
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota
state: Florida
city: Atlanta
country: United States
facility: Executive Health and Research Associates, Inc.
state: Georgia
city: Boise
country: United States
facility: Capital City Family Medicine
state: Idaho
city: Boise
country: United States
facility: Orthopedic Health Care Clinic
state: Idaho
city: Boise
country: United States
facility: Sonora Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: Chicago Research Center, Inc.
state: Illinois
city: Shawnee
country: United States
facility: Heart of America Research
state: Kansas
city: Baton Rouge
country: United States
facility: Dolby Research, LLC
state: Louisiana
city: Bangor
country: United States
facility: Acadia Clinical Research, LLC
state: Maine
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Cadillac
country: United States
facility: Professional Clinical Reserach -Great Lakes Family Care
state: Michigan
city: Saginaw
country: United States
facility: Synergy Medical Education Alliance
state: Michigan
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Pahrump
country: United States
facility: Specialty Medical Center
state: Nevada
city: Cooperstown
country: United States
facility: Bassett Healthcare
state: New York
city: Great Neck
country: United States
facility: DiGiovanna Family Care Center
state: New York
city: Great Neck
country: United States
facility: United Physicians Group - Endocrine Division
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Maumee
country: United States
facility: Fallen Timbers Internal Medicine LLC
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Reserch, LLC
state: Oklahoma
city: Medford
country: United States
facility: Cllinical Research Consultants
state: Oregon
city: Portland
country: United States
facility: Covance Clinical Research Unit, Inc
state: Oregon
city: Portland
country: United States
facility: Michael A. Azorr, M.D.
state: Oregon
city: Altoona
country: United States
facility: Keystone Clinical Solutions
state: Pennsylvania
city: Havertown
country: United States
facility: Southeastern PA Medical Institute
state: Pennsylvania
city: Lansdale
country: United States
facility: Greenand Seidner Family Practice
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Div of Endocrinology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Founders Medical Practice
state: Pennsylvania
city: Pittsburg
country: United States
facility: Research Endeavors
state: Pennsylvania
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Carrollton
country: United States
facility: John Joseph, MD PA
state: Texas
city: Dallas
country: United States
facility: Renaissance Clinical Research
state: Texas
city: Houston
country: United States
facility: MCA Research
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research, LTD
state: Texas
city: Plano
country: United States
facility: Professional for Clinical Research
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Benjamin Garwood Research
state: Texas
city: San Antonio
country: United States
facility: WellMed at Northern Hills
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Research Associates
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease - Westside office
state: Texas
city: Tacoma
country: United States
facility: Liberty Research Center
state: Washington
city: Charleston
country: United States
facility: Hyperion Clinical Trials, Inc.
state: West Virginia
Study officials:
affiliation: Ono Pharma USA Inc
name: Joseph G Bisaha, Ph.D.
role: STUDY_DIRECTOR
References: