Dose Ranging Study With LT, Monotherapy, PPAR

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00240383
First received: October 17, 2005
Last updated: September 10, 2010
Last verified: June 2008

October 17, 2005
September 10, 2010
May 2002
June 2006   (final data collection date for primary outcome measure)
To compare, after 24 weeks of oral administration of double-blind treatment, the change from baseline in hemoglobin A1c (HbA1c) achieved with the highest dose and subsequent doses of BMS-298585 versus the lowest dose of BMS-298585 in subjects with Type 2
Same as current
Complete list of historical versions of study NCT00240383 on ClinicalTrials.gov Archive Site
To assess, after 12 and 24 weeks of oral administration of double-blind therapy, the percent change from baseline in fasting lipids (total cholesterol,low density lipoprotein cholesterol,HDL-C, TG, non-HDL chol
Same as current
Not Provided
Not Provided
 
Dose Ranging Study With LT, Monotherapy, PPAR
A Randomized, Double-Blind, Dose Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects With Type 2 Diabetes

A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the Safety and Efficacy of BMS-298585 in Subjects with Type 2 Diabetes

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus II
Drug: Muraglitazar
Not Provided
Rubin CJ, Viraswami-Appanna K, Fiedorek FT. Efficacy and safety of muraglitazar: a double-blind, 24-week, dose-ranging study in patients with type 2 diabetes. Diab Vasc Dis Res. 2009 Jul;6(3):205-15. doi: 10.1177/1479164109336048.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1260
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1. HbA1c > 7.0% and ≤ 10.0% obtained at the Screening visit.
  • 2. Men and women, 18-70 years of age Established Type 2 diabetes

Exclusion Criteria:

  • 1. Symptomatic Type 2 diabetes defined as marked polyuria and polydipsia with greater than 10% weight loss during the last three months.
  • 2. Administration of antihyperglycemic agents (other than thiazolidinediones) for more than three consecutive or a total of seven non-consecutive days during the four weeks prior to screening.
  • 3. Administration of thiazolidinediones for more than three consecutive or a total of seven non-consecutive days during the six weeks prior to screening.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   France,   Italy,   Mexico,   Netherlands,   Poland,   Puerto Rico,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT00240383
CV168-006
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
June 2008

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