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

This study has been completed.

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00212641

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: ONO-5129	Phase II

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

Fasting Blood Glucose at 8 weeks

Secondary Outcome Measures:

Pharmacodynamic parameters at all time points

Estimated Enrollment:	105
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212641

Show 67 Study Locations

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Joseph G Bisaha, Ph.D.

Ono Pharma

More Information

Study ID Numbers:	ONO-5129POU006
Study First Received:	September 12, 2005
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00212641
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009