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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 33 (130 locations)

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