a trial comparing insulin degludec/liraglutide and insulin degludec in combination with metformin in chinese subjects with type 2 diabetes mellitus inadequately controlled with basal insulin therapy and metformin with or without one other oral antidiabetic drug (oad)

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to confirm the superiority of insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in chinese subjects with type 2 diabetes mellitus after 26 weeks of treatment


Eligibility criteria:
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 procedures to determine suitability for the trial - male or female, age at least 18 years at the time of signing inform consent - type 2 diabetes mellitus (clinically diagnosed) - hba1c (glycosylated haemoglobin) above or equal to 7.5% by central laboratory analysis, with the aim of a median of 8.5%. when approximately 50% of the randomised subjects have an hba1c above 8.5%, the remaining subjects randomised must have an hba1c below or equal to 8.5% or when approximately 50% of the subjects randomised have an hba1c below or equal to 8.5%, the remaining subjects randomised must have an hba1c above 8.5% - current treatment for at least 90 calendar days prior to screening with basal insulin plus metformin plus/minus α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. subjects should be on a stable dose for at least 60 calendar days prior to screening of: basal insulin 20-50 units (u)/day (both inclusive) ( individual fluctuations of plus/minus 5u during the 60 day period prior to the day of screening are acceptable.) on the day of screening in combination with: - metformin (above or equal to 1500 mg or max tolerated dose) or - metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or - metformin (above or equal to 1500 mg or max tolerated dose) and glinide (at least half of the max approved dose according to local label) or - metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (agi) (at least half of the max approved dose according to local label) or - metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (at least half of the max approved dose according to local label) - body mass index (bmi) above or equal to 24 kg/m\^2 exclusion criteria: current use of any antidiabetic drug (except for basal insulin, metformin, α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones) or anticipated change in concomitant medication, that in the investigator´s opinion could interfere with glucose level (e.g. systemic corticosteroids) - treatment with glucagon like peptide -1 receptor agonists, or dipeptidyl-peptidase-4 inhibitors or insulin (except for basal insulin) within 90 days prior to visit 1 - impaired liver function defined as alanine aminotransferase above or equal to 2.5 times upper normal range - impaired renal function defined as serum-creatinine above or equal to 133 μmol/l for males and above or equal to 125 μmol/l for females, or as defined according to local contraindications for metformin screening calcitonin above or equal to 50 ng/l - personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2) - 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 prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures - severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm hg or diastolic blood pressure above or equal to 100 mm hg) - proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment - history of pancreatitis (acute or chronic)