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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00212641
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: ONO-5129 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
Study Start Date : June 2005
Primary Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Fasting Blood Glucose at 8 weeks

Secondary Outcome Measures :
  1. Pharmacodynamic parameters at all time points


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212641


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Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Joseph G Bisaha, Ph.D. Ono Pharma USA Inc

Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT00212641     History of Changes
Other Study ID Numbers: ONO-5129POU006
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012

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