Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00106808
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-03-31
• Study First Submitted QC: 2005-03-31
• Study First Posted: 2005-04-01
• Study Start: 2005-08
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2007-09
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-10
• Last Update Submitted: 2010-09-10
• Disposition First Posted: 2010-09-14
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1440

Inclusion Criteria

• Type 2 Diabetes
• HbA1c > = 8.0% and < = 12.0%
• Serum triglyceride concentration < = 600 mg/dL
• Fasting c-peptide > = 1.0 ng/ml
• Body mass index < = 41 kg/m2
• Drug naive patients

Exclusion Criteria

• History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase.
• Women of child Bearing Potential
• Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase.
• History of renal disease, bladder cancer, pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HBA1c from baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks
Change for baseline in TG and HDL-C at Week 24
Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP.

Trial Locations

Locations (1)

Local Institution; 🇺🇦 Simferopol, Ukraine