Status:
COMPLETED
A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Diabetes, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.
Eligibility Criteria
Inclusion
- Subjects with Type 2 diabetes
- Drug Naive
- HbA1c \>= 7.0% and \<= 10.0%
- Body Mass Index \<= 41 kg/m2
- Serum TG \<= 600 mg/dL
Exclusion
- Symptomatic Type 2 diabetes
- History of bladder cancer
- History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT00246987
Start Date
June 1 2003
End Date
April 1 2004
Last Update
April 27 2012
Active Locations (130)
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1
Local Institution
Anniston, Alabama, United States
2
Local Institution
Birmingham, Alabama, United States
3
Local Institution
Haleyville, Alabama, United States
4
Local Institution
Hoover, Alabama, United States