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

September 12, 2005
October 10, 2012
June 2005
October 2007   (final data collection date for primary outcome measure)
Fasting Blood Glucose at 8 weeks
Same as current
Complete list of historical versions of study NCT00212641 on ClinicalTrials.gov Archive Site
Pharmacodynamic parameters at all time points
Same as current
Not Provided
Not Provided
 
A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: ONO-5129
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
Not Provided
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00212641
ONO-5129POU006
Not Provided
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
Ono Pharma USA Inc
Not Provided
Study Director: Joseph G Bisaha, Ph.D. Ono Pharma USA Inc
Ono Pharmaceutical Co. Ltd
October 2012

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