Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

CompletadoFase 3ClinicalTrials.gov

ID: NCT02128932Tipo: INTERVENTIONALInicio: 4 de ago de 2014Fin estimado: 3 de sept de 2015

Traducción no disponible, mostrando original

Resumen

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female, 18 years or older at the time of signing informed consent
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
History of chronic or idiopathic acute pancreatitis
Screening calcitonin value greater than or equal to 50 ng/L
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
Acute coronary or cerebrovascular event within 90 days before randomisation
Heart failure, New York Heart Association Class IV
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures

Criterios de exclusión

Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol

Intervenciones

drug

semaglutide

Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.

drug

insulin glargine

Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.

Ubicaciones

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

CABA, Argentina

Novo Nordisk Investigational Site

Capital Federal, Argentina

Novo Nordisk Investigational Site

Godoy Cruz, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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