Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: ONO-5129

Study type: Interventional

Funder types: Industry

Identifiers

NCT00335712

ONO-5129-03

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of ONO-5129 in patients with type 2 diabetes mellitus.

Enrollment: 81 patients

Sex: All

Ages: 45 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Fasting Blood Glucose 126-250mg/dL
2. HbA1c 6.5-11%

Exclusion criteria

1. Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization
2. History of myocardial infarction, coronary artery surgery
3. Other eligibility criteria as specified in the study protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind