Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

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 equal to
or above18 years at the time of signing informed consent - Diagnosed with type 2 diabetes
mellitus (T2D) - HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive) - Stable daily dose of
metformin (equal to or above1500 mg or maximum tolerated dose as documented in the subject
medical record and in compliance with current local label) for at least 90 days prior to
the day of screening Exclusion Criteria: - Known or suspected hypersensitivity to trial
product(s) or related products - Previous participation in this trial. Participation is
defined as signed informed consent - 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) -
Participation in any clinical trial of an approved or non-approved investigational
medicinal product within 90 days prior to the day of screening - Any disorder which in the
investigator's opinion might jeopardise subject's safety or compliance with the protocol -
Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - 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 (DKA) - Any of the following: myocardial
infarction (MI), 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 (NYHA) Class IV - Planned coronary, carotid or
peripheral artery revascularisation known on the day of screening - Renal impairment
measured as eGFR below 60 ml/min/1.73 m^2 as defined by Kidney Disease Improving global
outcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) for
serum creatinine measured at screening - 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 - 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 - Medical history of diabetes-related lower limb
amputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, or
gangrene) within the last 26 weeks prior to screening