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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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ono Pharmaceutical Co. Ltd:

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
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous participation in an ONO-5129 protocol
  2. Previous treatment with TZD agents or other current antidiabetics
  3. History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months
  4. Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe)
  5. 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 USA Inc
Investigators
Study Director: Joseph G Bisaha, Ph.D. Ono Pharma USA Inc
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT00212641     History of Changes
Other Study ID Numbers: ONO-5129POU006
Study First Received: September 12, 2005
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013