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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 9, 2006

Last Updated Date

July 28, 2008

Start Date ^†

June 2006

Current Primary Outcome Measures ^†

Fasting Blood Glucose at week 8

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00335712 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Type 2 Diabetes Mellitus

Intervention ^†

Drug: ONO-5129

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

45 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00335712

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Ono Pharma

Collaborators ^††

Investigators ^†

Study Director:

Project Leader, Development Planning

Ono Pharma

Information Provided By

Ono Pharma

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.