Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Muraglitazar (Drug); Pioglitazone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

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.

Official title: A Phase 3, Randomized, Double-Blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar (BMS-298585) Compared to Pioglitazone in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in HBA1c from baseline to Week 24

Secondary outcome:

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.

To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

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BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: August 2005
Last updated: September 27, 2007