Diabetes Mellitus, Type 2 MedDRA version: 15.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects with type 2 diabetes mellitus - Male or female = 18 years of age - HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive) - Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg OD Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (= 1500 mg or documented maximum tolerated dose) = 90 days prior to screening visit (Visit 1) - BMI (body mass index) = 40 kg/m2 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 321 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 108
Exclusion criteria
Exclusion criteria: - Any use of oral anti-diabetic drugs (OADs) (except for metformin) = 90 days prior to screening visit (Visit 1) - Use of any drug (except metformin and GLP-1 receptor agonist) which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids) - Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator) - Screening calcitonin = 50 ng/l - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures - Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator’s opinion - Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products - History of chronic pancreatitis or idiopathic acute pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superiority of insulin degludec/liraglutide versus unchanged glucagon-like peptide-1 (GLP-1) receptor agonist therapy in controlling glycaemia in insulin naïve subjects with type 2 diabetes mellitus (T2DM) inadequately controlled on GLP-1 receptor agonist therapy in combination with metformin.;Secondary Objective: To compare general efficacy and safety of insulin degludec/liraglutide versus unchanged GLP-1 receptor agonist therapy in insulin naïve subjects with T2DM inadequately controlled with GLP-1 receptor agonist therapy in combination with metformin after 26 weeks of treatment.;Primary end point(s): Change in glycosylated haemoglobin (HbA1c) from baseline (randomisation, Visit 2) ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Responders (Yes/No) achieving pre-defined target for HbA1c - HbA1c < 7.0% (53 mmol/mol) at end of treatment - HbA1c = 6.5% (48 mmol/mol) at end of treatment 2. Change from baseline in body weight 3 Change from baseline in fasting plasma glucose (FPG) 4. Number of severe or minor hypoglycaemic episodes 5. Number of adverse events (AEs) 6. Change from baseline in patient reported outcomes (PROs) based on the treatment related impact measure – diabetes (TRIM-D) and diabetes treatment satisfaction questionnaire (DTSQ);Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment 2., 3. After 26 weeks of treatment 4., 5. During 26 weeks of treatment 6. After 26 weeks of treatment | — |
Countries
Australia, European Union, Hungary, Slovakia, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed