Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094991
• Other study ID #: CV168-026
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2004
• Last updated: September 10, 2010
• Start date: May 2004
• Est. completion date: May 2006

Study information

• Verified date: September 2007
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Muraglitazar

Locations

Country	Name	City	State
Italy	Local Institution	Pisa
United States	Local Institution	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in insulin medicated glucose disposal after 16 weeks of treatment with Muraglitazar

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm