Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus.

CompletadoFase 3ClinicalTrials.gov

ID: NCT01144338Tipo: INTERVENTIONALInicio: 18 de jun de 2010Fin estimado: 24 de abr de 2017

Traducción no disponible, mostrando original

Resumen

This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Patient has type 2 diabetes mellitus
Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B) Insulin therapy, either alone or in combination with up to two oral agents
Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.

Criterios de exclusión

Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
Patient has ever been treated with an approved or investigational GLP-1 receptor agonist.
Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
Patient has a planned or anticipated revascularization procedure.
Pregnancy or planned pregnancy during the trial period.
Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m2.
Patient has a history of gastroparesis or pancreatitis.
Personal or family history of medullary thyroid cancer or MEN2 (Multiple EndocrineNeoplasia Type 2) or calcitonin level of \>40 ng/L at baseline.

Intervenciones

drug

Exenatide Once Weekly

Subcutaneous injection, 2 mg, administered once weekly.

drug

Placebo

Subcutaneous injection, matching volume of placebo, administered once weekly.

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

CABA, Argentina

Research Site

CABA, Argentina

Research Site

CABA, Argentina

Research Site

Capital Federal, Argentina

Research Site

CiudadAutonoma de Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Córdoba, Argentina

Research Site

Córdoba, Argentina

Research Site

Córdoba, Argentina

Research Site

Godoy Cruz, Argentina

Research Site

Mar Del Plata Buenos Aires, Argentina

Research Site

Rosario, Argentina

Research Site

Salta, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

San Salvador de Jujuy, Argentina

Research Site

Santa Rosa, Argentina

Patrocinadores

PrincipalAstraZeneca

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