A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00246987
First received: October 28, 2005
Last updated: April 26, 2012
Last verified: April 2012

October 28, 2005
April 26, 2012
June 2003
Not Provided
Change in HbA1c from baseline to Week 24
Same as current
Complete list of historical versions of study NCT00246987 on ClinicalTrials.gov Archive Site
Changes achieved from baseline in FPG after 24 weeks. Changes achieved from baseline in 3 hour post-prandial AUC for glucose and insulin levels after 24 weeks vs. placebo.
Same as current
Not Provided
Not Provided
 
A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes, Type 2
Drug: Muraglitazar
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
341
April 2004
Not Provided

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Mexico,   Poland,   Puerto Rico,   Taiwan
 
NCT00246987
CV168-018
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
April 2012

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