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

This study has been completed.

Sponsored by: Ono Pharma
Information provided by: Ono Pharma
ClinicalTrials.gov Identifier: NCT00335712
  Purpose

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


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

Further study details as provided by Ono Pharma:

Primary Outcome Measures:
  • Fasting Blood Glucose at week 8

Secondary Outcome Measures:
  • Other glycemic control parameters (e.g., HbA1c, glycoalbumin)

Enrollment:   81
Study Start Date:   June 2006

  Eligibility
Ages Eligible for Study:   45 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335712

Locations
Japan
Kanto Region    
      Kanto, Japan
Kyusyu Region    
      Kyusyu, Japan

Sponsors and Collaborators
Ono Pharma

Investigators
Study Director:     Project Leader, Development Planning     Ono Pharma    
  More Information


Study ID Numbers:   ONO-5129-03
First Received:   June 9, 2006
Last Updated:   July 28, 2008
ClinicalTrials.gov Identifier:   NCT00335712
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:
ONO-5129  
type 2 diabetes mellitus  

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 October 14, 2008

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