A Multicenter, Randomized, Double-Blind, Placebo-Controll... | EligiMed

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

CompletadoFase 3ClinicalTrials.gov

ID: NCT00968708Tipo: INTERVENTIONALInicio: 1 de sept de 2009Fin estimado: 1 de jun de 2013

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

Descripción detallada

Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor developed by Takeda for use in patients with type 2 diabetes mellitus. Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus patients who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome. This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in adults with type 2 diabetes mellitus and acute coronary syndrome.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Diagnosis of type 2 diabetes mellitus
Is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the participant's antidiabetic regimen includes insulin)
Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.

Criterios de exclusión

Signs of type 1 diabetes mellitus
Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.

Intervenciones

drug

Alogliptin

Alogliptin tablets

drug

Placebo

Alogliptin placebo matching tablets

Ubicaciones

Bahía Blanca, Argentina

Buenos Aires, Argentina

C0rdoba, Argentina

Capital Federal, Buenos Aires, Argentina

Capital Federal, Argentina

Carlos Paz, C0rdoba, Argentina

Ciudad Aut0noma de Buenos Aires, Argentina

Ciudad de C0rdoba, Argentina

Cordoba - Cordoba, Argentina

Corrientes, Argentina

Córdoba, Argentina

Derqui Pilar, Buenos Aires, Argentina

Formosa, Argentina

Haedo, Buenos Aires, Argentina

La Plata, Argentina

La Plata, Buenos Aires, Argentina

Mar del Plata, Argentina

Mar Del Plata, Provincia de Buenos Aires, Argentina

Mendoza, Argentina

Moron, Buenos Aires, Argentina

Olivos, Argentina

Quilmes, Argentina

Ramos Mejia, Buenos Aries, Argentina

Ramos Mejía, Argentina

Rosario, Argentina

Rosario - Santa Fe, Argentina

Rosario, Provincia de Santa Fe, Argentina

Salta, Argentina

San Isidro, Argentina

San Juan, San Juan, Argentina

San Justo, Argentina

San Luis, Argentina

San Miguel de Tucumán, Argentina

San Salvador de Jujuy, Argentina

Santa Fe, Argentina

Trelew, Chubut, Argentina

Villa María, Argentina

Patrocinadores

PrincipalTakeda

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