Type 2 diabetes MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Insulin degludec/liraglutide
Product Code: NNC 0100-0454/ NNC 90-1170
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin degludec
CAS Number: 844439-96-9
Current Sp
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion 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 • Subjects on stable dose of 1-2 OADs (metformin [= 1500 mg or max tolerated dose] or metformin [= 1500 mg or max tolerated dose] + pioglitazone [= 30 mg]) for at least 90 days prior to screening • BMI = 40 kg/m^2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) • Treatment with GLP-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) = 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 = 133 µmol/l (= 1.5 mg/dl) for males and = 125 µmol/l (= 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 = 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 = 180 mm Hg or diastolic blood pressure = 100 mm Hg) • Acute treatment required proliferative retinopathy or maculopathy (macular oedema) • History of chronic pancreatitis or idiopathic acute pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in subjects with type 2 diabetes. This is done by comparing the difference in change in HbA1c from baseline after 26 weeks of treatment to a non-inferiority limit of 0.3% for insulin degludec/liraglutide vs insulin degludec and to a superiority limit of 0% for insulin degludec/liraglutide vs liraglutide.;Secondary Objective: • To confirm superiority of insulin degludec/liraglutide vs insulin degludec after 26 weeks of treatment on either weight control, hypoglycaemic episodes, glycaemic control in relation to a meal, or glycaemic control as indirectly measured by daily dose of insulin degludec • To compare general efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide after 26 and 52 weeks of treatment • To confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in subjects with type 2 diabetes after 52 weeks of treatment ;Primary end point(s): Change from baseline in HbA1c after 26 weeks of treatment | — |
Countries
Finland, Germany, Hungary, Ireland, Italy, Slovakia, Spain, United Kingdom
Outcome results
None listed