a trial comparing insulin degludec/liraglutide, insulin degludec, and liraglutide in chinese subjects with type 2 diabetes inadequately controlled on oral antidiabetic drugs (oads)

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents


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 activities to determine suitability for the trial * type 2 diabetes mellitus (clinically diagnosed) * male or female, age at least 18 years at the time of signing informed consent * hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a median of8.3%. when approximately 50% of the randomised subjects have an hba1c above 8.3%, the remaining subjects randomised must have an hba1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have an hba1c below or equal to 8.3%, the remaining subjects randomised must have an hba1c above 8.3% * current treatment for at least 90 calendar days prior to screening with metformin plus/minus one other oad: α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. for above or equal to 60 calendar days prior to screening subjects should be on a stable dose of: * 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 glinides (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 α-glucosidase inhibitors (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 thiazolidinediones (above or equal to half of the max approved dose according to local label) exclusion criteria: * treatment with insulin (except for short-term treatment at the discretion of the investigator) * treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening * 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 mmhg or diastolic blood pressure above or equal to 100 mmhg * proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment * history of pancreatitis (acute or chronic)