A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

CompletadoFase 3ClinicalTrials.gov

ID: NCT02692716Tipo: INTERVENTIONALInicio: 17 de ene de 2017Fin estimado: 25 de sept de 2018

Traducción no disponible, mostrando original

Resumen

This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Male or female diagnosed with type 2 diabetes
Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor

Criterios de exclusión

Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide
Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
History of pancreatitis (acute or chronic)
History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m\^2)
History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

Intervenciones

drug

semaglutide

For oral use once daily.

drug

placebo

For oral use once daily.

Ubicaciones

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

CABA, Argentina

Novo Nordisk Investigational Site

CABA, Argentina

Novo Nordisk Investigational Site

CABA, Argentina

Novo Nordisk Investigational Site

Córdoba, Argentina

Novo Nordisk Investigational Site

Lanús Este, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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