Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

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, above or equal to 18 years at the time of signing informed consent.
For Japan only: Male or female, age equal to or above 20 years at the time of signing
informed consent

- Diagnosed with type 2 diabetes mellitus

- HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)

- Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including
fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500
mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of
screening. All medications in compliance with current local label

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)

- Any disorder which in the investigator's opinion might jeopardise subject's safety or
compliance with the protocol

- Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria within the past 90 days prior to the day of
screening. However, short term insulin treatment for a maximum of 14 days prior to the
day of screening is allowed

- Subjects with alanine aminotransferase above 2.5 x upper normal limit

- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid
carcinoma. Family is defined as a first degree relative

- History or presence of pancreatitis (acute or chronic)

- History of diabetic ketoacidosis

- Any of the following: myocardial infarction, stroke, hospitalization for unstable
angina 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 Class IV

- Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening

- Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below
60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass
spectrometry for serum creatinine measured at screening

- Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
photography or dilated fundoscopy performed within the past 90 days prior to
randomisation

- Presence or history of malignant neoplasms within the past 5 years prior to the day of
screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed