A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria: - Male or female, age greater than or equal to 18 years at the time of
signing informed consent - Subjects diagnosed with type 2 diabetes mellitus - HbA1c
7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis - Body mass
index greater than or equal to 20 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 is
prior insulin treatment for gestational diabetes - Stable daily dose(s) including any of
the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening:
a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose
documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea,
glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum
approved dose according to local label or maximum tolerated dose as documented in subjects
medical record) Exclusion Criteria: - Screening calcitonin greater than or equal to 50 ng/L
- Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m^2
as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for
serum creatinine measurement on the day of screening - Impaired liver function, defined as
ALAT or ASAT greater than or equal to 2.5 times upper limit of normal - Family or personal
history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - History of
pancreatitis (acute or chronic) - 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 - Anticipated initiation or change in concomitant medications
for more than 14 consecutive days or on a frequent basis known to affect weight or glucose
metabolism (e.g. orlistat, thyroid hormones, corticosteroids)