Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus

CompletadoFase 3ClinicalTrials.gov

ID: NCT02849080Tipo: INTERVENTIONALInicio: 20 de sept de 2016Fin estimado: 27 de mar de 2019

Traducción no disponible, mostrando original

Resumen

This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, age above or equal to 18 years at the time of signing informed consent. For Korea only: Male or female, age above or equal to 19 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening
HbA1c (glycosylated haemoglobin) 7.5-9.5% (58-80 mmol/mol) (both inclusive)
Treatment target of HbA1c below 7.0% (53 mmol/mol), as judged by the investigator
Stable daily dose(s) of 1-2 of the following anti-diabetic drugs within 90 days prior to the day of screening:
Metformin (equal or above 1500 mg or maximum tolerated dose as documented in the subject medical record)
Sulfonylureas (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
Sodium glucose co-transporter 2 inhibitors
Thiazolidinediones (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
Extension phase:
Informed consent for the extension phase obtained before any trial-related activities for the extension phase.
On randomised treatment with or without rescue medication at week 52.
Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
History of diabetic ketoacidosis

Criterios de exclusión

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). For certain specific countries: Additional specific requirements apply
Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
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)
Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation
Subjects presently classified as being in New York Heart Association Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Subjects with alanine aminotransferase above 2.5 x upper normal limit
Renal impairment defined as Estimated Glomerular Filtration rate 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula

Intervenciones

drug

semaglutide

Oral administration once-daily.

drug

sitagliptin

Oral administration once-daily.

Ubicaciones

Novo Nordisk Investigational Site

CABA, Argentina

Novo Nordisk Investigational Site

Corrientes, Argentina

Novo Nordisk Investigational Site

Rosario, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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