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

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 2

In brief

The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus

Key facts

Study ID

NCT00212641

Run by

Ono Pharma USA Inc

People needed

105

Starts

2005-06-01

Last updated by the study team

2012-10-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• Other Inclusion criteria as specified in the study protocol

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)
• Other exclusion criteria as specified in the study protocol

Where it is running

• Greystone Medical Research, LLC — Birmingham, Alabama, United States
• Med Search, LLC — Calera, Alabama, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States
• Clinic of Physicians and Surgeons — Mesa, Arizona, United States
• Horizon Clinical Research Associates — Mesa, Arizona, United States
• Cochise Clinical Research — Sierra Vista, Arizona, United States
• Sagebrush Medical Plaza, Department of Family Medicine — Bakersfield, California, United States
• Family Medical Center — Foothill Ranch, California, United States
• Prime-Care Clinical Research — Mission Viejo, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Orange County Research Center — Tustin, California, United States
• Quality Care Medical Center — Vista, California, United States
• Arapahoe Internal Medicine — Littleton, Colorado, United States
• Institute Diabetes and Metabolic Disease — Newark, Delaware, United States
• Alliance Medical Reserach Group, Inc. — Clearwater, Florida, United States
• Personal Physician Care — Delray Beach, Florida, United States
• Century Clinical Research, Inc — Holly Hill, Florida, United States
• Innovative Research of West Florida — Largo, Florida, United States
• Cardiovascular Center of Sarasota — Sarasota, Florida, United States
• Executive Health and Research Associates, Inc. — Atlanta, Georgia, 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
• Cedar-Crosse Research Center — Chicago, Illinois, United States
• Apex Clinical Trials, Inc. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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