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
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus II
Drug: Muraglitazar
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1260
Study Start Date: May 2002
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240383

  Show 272 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00240383     History of Changes
Other Study ID Numbers: CV168-006
Study First Received: October 17, 2005
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 14, 2014