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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 17, 2005
Last Updated Date	September 10, 2010
Start Date ^ICMJE	May 2002
Primary Completion Date	June 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 17, 2005)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00240383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 17, 2005)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dose Ranging Study With LT, Monotherapy, PPAR
Official Title ^ICMJE	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
Brief Summary	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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Diabetes Mellitus II
Intervention ^ICMJE	Drug: Muraglitazar
Study Arm (s)	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1260
Completion Date	June 2006
Primary Completion Date	June 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Brazil, Canada, Czech Republic, France, Italy, Mexico, Netherlands, Poland, Puerto Rico, South Africa, Spain, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00240383
Other Study ID Numbers ^ICMJE	CV168-006
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bristol-Myers Squibb
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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