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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00106808Tipo: INTERVENTIONALInicio: 1 de ago de 2005Fin estimado: 1 de ago de 2006

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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.

Intervenciones

drug

Muraglitazar

drug

Pioglitazone

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Chacabuco, Chaco Province, Argentina

Local Institution

Corrientes, Corrientes Province, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Santa Fe, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorMerck Sharp & Dohme LLC

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