Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

Inclusion Criteria:

• Male or female, age at least 18 years at the time of signing informed consent ForJapan only: Male or female, age at least 20 years at the time of signing informedconsent
• Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day ofscreening
• HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
• Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose asdocumented in subject medical record) alone or in combination with SU (= half of themaximum approved dose according to local label or maximum tolerated dose as documentedin subject medical record) within 90 days prior to the day of screening

Exclusion Criteria:

• Female who is pregnant, breast-feeding or intends to become pregnant or is ofchild-bearing potential and not using adequate contraceptive methods (adequatecontraceptive measures as required by local regulation or practice). For certainspecific countries: Additional specific requirements apply
• Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or MedullaryThyroid Carcinoma (MTC)
• History of pancreatitis (acute or chronic)
• History of major surgical procedures involving the stomach potentially affectingabsorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,gastric bypass surgery)
• Any of the following: myocardial infarction, stroke or hospitalization for unstableangina and/or transient ischaemic attack within the past 180 days prior to the day ofscreening
• Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
• Planned coronary, carotid or peripheral artery revascularisation known on the day ofscreening.
• Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
• History or presence of malignant neoplasms within the last 5 years (except basal andsquamous cell skin cancer and in-situ carcinomas)