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

June 12, 2012 updated by: Ono Pharma USA Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kanto, Japan
        • Kanto region
      • Kyusyu, Japan
        • Kyusyu region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fasting Blood Glucose at week 8

Secondary Outcome Measures

Outcome Measure
Other glycemic control parameters (e.g., HbA1c, glycoalbumin)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharma USA Inc

Investigators

  • Study Director: Project Leader, Development Planning, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Registration Dates

First Submitted

June 9, 2006

First Submitted That Met QC Criteria

June 9, 2006

First Posted (Estimate)

June 12, 2006

Study Record Updates

Last Update Posted (Estimate)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-5129-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on ONO-5129

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe