Comparación de la Adición de Exenatida versus el Cambio a Exenatida en Pacientes con Diabetes Mellitus Tipo 2 con Control Glucémico Inadecuado con Sitagliptina más Metformina

CompletadoFase 4ClinicalTrials.gov

ID: NCT00870194Tipo: INTERVENTIONALInicio: 1 de mar de 2009Fin estimado: 1 de abr de 2010

Resumen

El propósito de este estudio es determinar si el cese de sitagliptina y el cambio a exenatida y metformina no es inferior a la adición de exenatida a sitagliptina y metformina, en aquellos pacientes con diabetes mellitus tipo 2 que presentan un control glucémico inadecuado con la combinación de sitagliptina y metformina.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Present with type 2 diabetes
Patients have been treated with a stable dose of the following for at least 3 months prior to screening:
mg/day sitagliptin and
≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).
Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.
Have a body mass index (BMI) ≥20 kg/m2 and \<45 kg/m2

Criterios de exclusión

Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have previously completed or withdrawn from this study or any other study investigating exenatide.
Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.
Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.
Are currently treated with any of the following excluded medications:
Thiazolidinediones (TZD) within 3 months of screening.
Sulfonylurea (SU) within 3 months of screening.
Dipeptidyl peptidase-4 \[DPP-4\] inhibitors, with the exception of sitagliptin, within 3 months of screening.
Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
Exogenous insulin within the 3 months prior to screening.
Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.
Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.

Intervenciones

drug

exenatide and sitagliptin

exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day

drug

exenatide and placebo

exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Morón, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorEli Lilly and Company

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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