efficacy and safety of oral semaglutide using a flexible dose adjustment based on clinical evaluation versus sitagliptin in subjects with type 2 diabetes mellitus.

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: 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.


Eligibility criteria:
inclusion criteria: main phase (the inclusion criteria for the main phase are not reassessed for the extension phase): * 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. exclusion criteria: main phase (the exclusion criteria for the main phase are not reassessed for the extension phase): * 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 * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. an exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days * 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 extension phase: there are no new exclusion criteria for the extension phase