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

NCT ID: NCT00335712

Last Updated: 2012-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ONO-5129

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharma USA Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader, Development Planning

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Kanto Region

Kanto, , Japan

Site Status

Kyusyu Region

Kyusyu, , Japan

Site Status

Countries

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Japan

Other Identifiers

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ONO-5129-03

Identifier Type: -

Identifier Source: org_study_id

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