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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ono Pharma USA Inc

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