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Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00094991
First received: October 29, 2004
Last updated: September 10, 2010
Last verified: September 2007
History of Changes
  Purpose

The purpose of this study is to learn more about how muraglitazar lowers blood sugar in people with type 2 diabetes. The safety of this treatment will also be studied.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 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: Mechanism of Action and Efficacy of Muraglitazar (BMS298585) in the Treatment of Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The change from baseline in insulin medicated glucose disposal after 16 weeks of treatment with Muraglitazar

Estimated Enrollment: 42
Study Start Date: May 2004
Study Completion Date: May 2006
Primary Completion Date: May 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:

  • Type 2 diabetes;
  • Serum triglyceride concentration < or = 600 mg/dL;
  • Body mass index < or = 37 kg/m2

Exclusion Criteria:

  • Type 1 diabetes;
  • History of myocardial infarction (MI), coronary angioplasty, bypass graft(s), valvular disease, unstable angina pectoris, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within 6 months;
  • Congestive heart failure (NYHA Class III and IV);
  • Uncontrolled hypertension;
  • Women of Child Bearing Potential
  • 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: NCT00094991

Locations
United States, Texas
Local Institution
San Antonio, Texas, United States, 78229-3900
Italy
Local Institution
Pisa, Italy
Sponsors and Collaborators
Bristol-Myers Squibb
Merck
  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: NCT00094991     History of Changes
Other Study ID Numbers: CV168-026
Study First Received: October 29, 2004
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glycine
 Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013