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
  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:


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
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: NCT00162240

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

Additional Information:
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 July 20, 2014