A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Glyburide Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone

CompletadoFase 3ClinicalTrials.gov

ID: NCT00162175Tipo: INTERVENTIONALInicio: 1 de jul de 2003Fin estimado: 1 de nov de 2005

Traducción no disponible, mostrando original

Resumen

A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Glyburide Therapy in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sulfonylurea Therapy Alone.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Type 2 Diabetes, HbA1c \> 7.0% and \< 10.0%, mean serum triglyceride \< 600 mg/dL, body mass index \< 41 kg/m2, fasting c-peptide . 1.5 ng/mL.

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 attack, or cerebrovascular accident (CVA) within 6 months, congestive heart failure (NYHA Class III and IV, uncontrolled hypertension, history or renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Intervenciones

drug

Muraglitazar

Ubicaciones

Local Institution

Bahía Blanca, Buenas Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Mendoza, Mendoza Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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