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PPAR - Combination With Metformin

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ClinicalTrials.gov Identifier: NCT00162240
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 27, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Muraglitazar Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2003
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162240


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

Additional Information:
ClinicalTrials.gov Identifier: NCT00162240     History of Changes
Other Study ID Numbers: CV168-022
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

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