A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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