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

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: ONO-5129

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212641

ONO-5129POU006

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind