Status:
COMPLETED
A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus
Lead Sponsor:
Ono Pharma USA Inc
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00212641
Start Date
June 1 2005
Last Update
October 11 2012
Active Locations (67)
Enter a location and click search to find clinical trials sorted by distance.
1
Apex Clinical Trials, Inc.
Birmingham, Alabama, United States, 35209
2
Greystone Medical Research, LLC
Birmingham, Alabama, United States, 35242
3
Med Search, LLC
Calera, Alabama, United States, 35040
4
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801