Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes

Inclusion Criteria:

• Subjects with type 2 diabetes

• HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly,when approximately 50% of the randomised subjects have a HbA1c above 8.3%, theremaining subjects randomised must have a HbA1c of below or equal to 8.3%, or whenapproximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%,the remaining subjects randomised must have a HbA1c above 8.3%

• Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 inTaiwan: Taichung Veterans General Hospital)

• Subjects on stable dose of 1-2 OADs (metformin [at least 1500 mg or max tolerateddose] or metformin [at least 1500 mg or max tolerated dose] + pioglitazone [at least 30 mg]) for at least 90 days prior to screening

• Body Mass Index (BMI) maximum 40 kg/m^2

Exclusion Criteria:

• Treatment with insulin (except for short-term treatment due to intercurrent illness atthe discretion of the Investigator)

• Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide,liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90days prior to trial

• Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 timesUpper Normal Range (UNR) (one retest analysed at the central laboratory within a weekfrom first sample taken is permitted with the result of the last sample being theconclusive)

• Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowedaccording to local contraindications for metformin (one retest analysed at the centrallaboratory within a week from first sample taken is permitted with the result of thelast sample being the conclusive)

• Screening calcitonin at least 50 ng/L

• Subjects with personal or family history of medullary thyroid carcinoma (MTC) ormultiple endocrine neoplasia type 2 (MEN 2)

• Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosisof unstable angina pectoris, cerebral stroke and/or myocardial infarction within thelast 12 months and planned coronary, carotid or peripheral artery revascularisationprocedures

• Severe uncontrolled treated or untreated hypertension (systolic blood pressure atleast 180 mm Hg or diastolic blood pressure at least 100 mm Hg)

• Acute treatment required proliferative retinopathy or maculopathy (macular oedema)

• History of chronic pancreatitis or idiopathic acute pancreatitis