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PPAR - Combination With Metformin

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162240
First received: September 9, 2005
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone


Condition Intervention Phase
Diabetes Mellitus
 Drug: Muraglitazar
 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 Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + metformin vs placebo + metformin

Secondary Outcome Measures:
  • change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24

Estimated Enrollment: 534
Study Start Date: June 2003
Study Completion Date: May 2004
  Eligibility

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

Inclusion Criteria:

  • Type 2 Diabetes
  • HbA1c > - 7.0% and < - 10.0 %
  • Mean serum triglyceride < - 600 mg/dL
  • Body mass index < - 41 kg/m2
  • Fasting c-peptide > - 1.0 ng/mL

Exclusion Criteria:

  • History of myocardial infarction (MI)
  • coronary angioplasty or bypass graft(s)
  • valvular disease or repair
  • unstable angina pectoris
  • transient ischemic attack (TIA), cerebrovascular attack, or cerebrovascular accident (CVA) within 6 months
  • Congestive heart failure NYHA Class III and IV
  • Uncontrolled hypertension
  • History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162240

  Show 203 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00162240     History of Changes
Other Study ID Numbers: CV168-022
Study First Received: September 9, 2005
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Metabolics Diabetes New Onset

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013