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PPAR-COMBO With Sulfonylurea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162175
First Posted: September 13, 2005
Last Update Posted: September 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.

Condition Intervention Phase
Metabolics Diabetes Nos Drug: Muraglitazar Phase 3

Study Type: Interventional
Study Design: 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 Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea 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 + glyburide vs placebo + glyburide

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: July 2003
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

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 . 1.5 ng/mL.

Exclusion Criteria:

  • History of MI (myocardial infarction), 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 or 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): NCT00162175


  Show 150 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00162175     History of Changes
Other Study ID Numbers: CV168-021
First Submitted: September 9, 2005
First Posted: September 13, 2005
Last Update Posted: September 14, 2010
Last Verified: September 2007