Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes

September 10, 2010 updated by: Bristol-Myers Squibb

Mechanism of Action and Efficacy of Muraglitazar (BMS298585) in the Treatment of Type 2 Diabetic Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy
        • Local Institution
  • United States
    • Texas
      • San Antonio, Texas, United States, 78229-3900
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The change from baseline in insulin medicated glucose disposal after 16 weeks of treatment with Muraglitazar

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

October 29, 2004

First Submitted That Met QC Criteria

October 29, 2004

First Posted (Estimate)

November 1, 2004

Study Record Updates

Last Update Posted (Estimate)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 10, 2010

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV168-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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