Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Pioglitazone

Drug: Muraglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT00106808

CV168-062

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.