A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes

CompletadoFase 4ClinicalTrials.gov

ID: NCT01107886Tipo: INTERVENTIONALInicio: 1 de may de 2010Fin estimado: 1 de may de 2013

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

Descripción detallada

A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Patients with type 2 diabetes mellitus
HbA1c ≥6.5%. (based on the last measured and documented laboratory measurement within 6 months)
High risk for CV events -Established cardiovascular disease and/or multiple risk factors

Criterios de exclusión

Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
Acute vascular event \<2months prior to randomisation

Intervenciones

drug

Saxagliptin

5 mg or 2.5 mg once daily

drug

Placebo

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Ciudad Autonom de Buenos Aires, Argentina

Research Site

CiudadAutonoma de Buenos Aires, Argentina

Research Site

Corrientes, Argentina

Research Site

Córdoba, Argentina

Research Site

La Plata, Argentina

Research Site

Lanus Buenos Aires, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Mendoza, Argentina

Research Site

Morón, Argentina

Research Site

Ramos Mejía, Argentina

Research Site

Rosario, Argentina

Research Site

Rosario Santa Fe, Argentina

Research Site

Santa Fe, Argentina

Research Site

Sarandi Buenos Aires, Argentina

Research Site

Villa Ballester, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorBristol-Myers Squibb

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