Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

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
• Japanese male or female, age above or equal to 20 years at the time of signinginformed consent
• Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening
• HbA1c 6.5%-9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oralantidiabetic drug as monotherapy and 7.0%-10.0% (53-86 mmol/mol) (both inclusive) forsubjects treated with diet and exercise therapy alone
• Treatment for at least 30 days prior to day of screening with;- stable daily dose oforal anti-diabetic drug as monotherapy (allowed oral anti-diabetic drugs are:metformin, sulphonylurea, glinide, α-glucosidase inhibitor, dipeptidyl peptidase-4inhibitor and sodium-glucose cotransporter-2 inhibitor) at a half-maximum approveddose or below according to Japanese labelling in addition to diet and exercisetherapy. or - diet and exercise therapy alone

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 measures are abstinence (not having sex), diaphragm, condom (by thepartner), intrauterine device, sponge, spermicide or oral contraceptives
• 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, stroke or hospitalisation for unstableangina or transient ischaemic attack within the past 180 days prior to the day ofscreening and randomisation
• Subject 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 alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)
• Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 30mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
• Treatment with once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), onceweekly dipeptidyl peptidase-4 (DPP-4) inhibitor or thiazolidinedione in a period of 90days before the day of screening
• Treatment with any medication for the indication of diabetes or obesity other thanstated in the inclusion criteria in a period of 60 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 in-situ carcinomas)
• Initiation of anti-diabetic medication between the day of screening and the day ofrandomisation