Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes

This study has been completed.

Sponsors and Collaborators:	Bristol-Myers Squibb Merck
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00094991

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 III

MedlinePlus related topics: Diabetes

Drug Information available for: Muraglitazar

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Mechanism of Action and Efficacy of Muraglitazar (BMS298585) in the Treatment of Type 2 Diabetic Patients

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

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

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

Study ID Numbers:	CV168-026
Study First Received:	October 29, 2004
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00094991
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Type 2 diabetes

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009