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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00335712
• Lead Sponsor: Ono Pharma USA Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-09
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fasting Blood Glucose at week 8

Secondary Outcome Measures

Name	Time	Method
Other glycemic control parameters (e.g., HbA1c, glycoalbumin)

Trial Locations

Locations (2)

Kanto Region; 🇯🇵 Kanto, Japan

Kyusyu Region; 🇯🇵 Kyusyu, Japan