Clinical trial NCT01336023 (phase 3, status: completed)
Conditions: diabetes, diabetes mellitus, type 2
ICD codes: E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65, E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: insulin degludec/liraglutide, insulin degludec, liraglutide
SMILES: CN(C)C(=N)NC(N)=N, [Na+].[Na+].[O-]P([O-])(F)=O, CN(C)C(=N)NC(N)=N
Eligibility criteria:

        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%, the
             remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when
             approximately 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 in
             Taiwan: Taichung Veterans General Hospital)

          -  Subjects on stable dose of 1-2 OADs (metformin [at least 1500 mg or max tolerated
             dose] 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 at
             the 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 90
             days prior to trial

          -  Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times
             Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week
             from first sample taken is permitted with the result of the last sample being the
             conclusive)

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

          -  Screening calcitonin at least 50 ng/L

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

          -  Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis
             of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the
             last 12 months and planned coronary, carotid or peripheral artery revascularisation
             procedures

          -  Severe uncontrolled treated or untreated hypertension (systolic blood pressure at
             least 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