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Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00094991
Recruitment Status : Completed
First Posted : November 1, 2004
Last Update Posted : September 14, 2010
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Muraglitazar Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Mechanism of Action and Efficacy of Muraglitazar (BMS298585) in the Treatment of Type 2 Diabetic Patients
Study Start Date : May 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


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;
  • 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

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): 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 Sharp & Dohme Corp.

Additional Information:
ClinicalTrials.gov Identifier: NCT00094991     History of Changes
Other Study ID Numbers: CV168-026
First Posted: November 1, 2004    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2007

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
Physiological Effects of Drugs