Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-relatedactivities are any procedures that are carried out as part of the trial, includingactivities to determine suitability for the trial
• Male or female, age above or equal to 18 years at the time of signing informedconsent. For Japan only: Male or female, age at least 20 years at the time of signinginformed consent
• Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day ofscreening.
• HbA1c (glycosylated haemoglobin) of 7.0-9.5 % (53-80.3 mmol/mol) (both inclusive)
• Stable daily dose of metformin (above or equal to 1500 mg or maximum tolerated dose asdocumented in the subject medical record) alone or in combination with a stable dailydose of a SGLT-2 (sodium-glucose co-transporter-2) inhibitor for at least 90 daysprior to day of screening (fixed-dose combinations are allowed)

Exclusion Criteria:

• Female who is pregnant, breast-feeding or intends to become pregnant or is ofchild-bearing potential and not using an adequate contraceptive method (adequatecontraceptive measure as required by local regulation or practice).For certainspecific countries: Additional specific requirements apply
• Any disorder, which in the investigator's opinion might jeopardise subject's safety orcompliance with the protocol
• 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 and potentially affectingabsorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,gastric bypass surgery)
• Any of the following: myocardial infarction (MI), stroke or hospitalisation forunstable angina or transient ischaemic attack within the past 180 days prior to theday 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 ofscreening
• Subjects with ALT (alanine aminotransferase) above 2.5 × upper normal limit (UNL)
• Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
• Treatment with any medication for the indication of diabetes or obesity other thanstated 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 orequal to 14 days
• Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundusphotography or dilated fundoscopy performed within 90 days prior to randomisation
• History or presence of malignant neoplasms within the last 5 years (except basal andsquamous cell skin cancer and carcinoma in situ)
• History of diabetic ketoacidosis