A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0%
[53-97 mmol/mol] (both inclusive) by central laboratory analysis - Body mass index (BMI)
equal to or above 20 kg/m^2 and below 40 kg/m^2 - Insulin naïve subjects; however short
term insulin treatment for a maximum of 14 days prior to the day of screening is allowed,
as well as prior insulin treatment for gestational diabetes - A stable daily dose for at
least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination
with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects
treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal
product within 90 days prior to screening - Use of any OADs (other than SGLT2i in
monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the
inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like
peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to
the day of screening - Acute decompensation of glycaemic control requiring immediate
intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes
ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects
presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal
impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic
Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT
(alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening -
Known or suspected hypersensitivity to trial product(s) or related products