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 For Japan only: Male or female, age at least 20 years at the time of signing
informed consent - Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days
prior to day of screening - 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 as documented in subject medical record) alone or in combination with SU (=
half of the maximum approved dose according to local label or maximum tolerated dose as
documented in 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 of child-bearing potential and not using adequate contraceptive methods (adequate
contraceptive measures as required by local regulation or practice).For certain specific
countries: Additional specific requirements apply - 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) - Any of the following: myocardial
infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack
within the past 180 days prior to the day of screening - Subjects presently classified as
being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or
peripheral artery revascularisation known on the day of screening. - Renal impairment
defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/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 and squamous cell skin cancer and
in-situ carcinomas)