A Phase 3, Randomized, Three-Arm, Double-blind, Active Controlled, Parallel Group, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Subjects Wtih Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

CompletadoFase 3ClinicalTrials.gov

ID: NCT00095030Tipo: INTERVENTIONALInicio: 1 de feb de 2004Fin estimado: 1 de mar de 2006

Traducción no disponible, mostrando original

Resumen

The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Subject with Type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening
HbA1c \>or = 7% and \< or = 10%
Fasting c-peptide \> or = 1.0 umol
Body Mass Index \< or = 41 kg/m2
Mean serum triglycerides \< or = 600 mg/dl

Intervenciones

drug

muraglitazar

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Chacabuco, Buenos Aires, Argentina

Local Institution

El Palomar, Buenos Aires, Argentina

Local Institution

Mar del Plata, Buenos Aires, Argentina

Local Institution

San Martín, Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Córdoba, Argentina

Local Institution

Mendoza, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorMerck Sharp & Dohme LLC

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