Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

Inclusion Criteria: - 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 - Diagnosed with type 2 diabetes
mellitus for at least 90 days prior to day of screening - HbA1c (glycosylated haemoglobin)
of 7.0-9.5% (53-80 mmol/mol) (both inclusive) - Moderate renal impairment defined as
estimated glomerular filtration rate of 30-59 mL/min/1.73 m^2 as per Chronic Kidney Disease
Epidemiology Collaboration formula - Stable daily dose(s) within 90 days prior to the day
of screening of any of the following treatment regimens:- 1-2 of the following oral
anti-diabetic drugs: - Metformin equal or above 1500 mg or maximum tolerated dose
documented in the subject medical record), - Sulfonylurea (equal or above half of the
maximum approved dose according to local label or maximum tolerated dose as documented in
subject medical record) - Basal insulin alone (20% change in total daily dose of insulin
glargine, insulin detemir, insulin degludec or NPH insulin) or - Metformin (equal or above
1500 mg or maximum tolerated dose documented in the subject medical record) in combination
with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir,
insulin degludec or NPH insulin) Exclusion Criteria: - 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 - Rapidly progressing renal disease (e.g. such as acute
glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (above
2200 mg/24 hours or above 2200 mg/g) - Use of systemic immunosuppressive treatment within
90 days prior to screening - 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 - Known hypoglycaemic unawareness and/or recurrent
severe hypoglycaemic episodes as judged by the investigator - 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)