A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

ClinicalTrials.gov Identifier:

NCT00212641

First received: September 12, 2005

Last updated: October 10, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 10, 2012

Start Date ^ICMJE

June 2005

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Fasting Blood Glucose at 8 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00212641 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacodynamic parameters at all time points

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus

Official Title ^ICMJE

Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus

Brief Summary

The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: ONO-5129

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

105

Completion Date

Not Provided

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 Diabetes Mellitus
FBG level > 140 mg/dL and < 270 mg/dL
Fasting TG level < 500 mg/dL
BMI of 22 to 40 kg/m2, inclusive
Other Inclusion criteria as specified in the study protocol

Exclusion Criteria:

Previous participation in an ONO-5129 protocol
Previous treatment with TZD agents or other current antidiabetics
History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months
Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe)
Other exclusion criteria as specified in the study protocol

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00212641

Other Study ID Numbers ^ICMJE

ONO-5129POU006

Has Data Monitoring Committee

Not Provided

Responsible Party

Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

Study Sponsor ^ICMJE

Ono Pharma USA Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Joseph G Bisaha, Ph.D.

Ono Pharma USA Inc

Information Provided By

Ono Pharmaceutical Co. Ltd

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top