Type 2 diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Victoza®
Product Name: Victoza®
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men or women with type 2 diabetes • Age = 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age = 60 years at screening and other specified risk factors of vascular disease • HbA1c = 7.0% at screening 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: • Type 1 diabetes • Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any (dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening • Use of insulin other than human neutral protamine hagedorn (NPH) insulin or long-acting insulin analogue within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed at Investigator’s discretion • Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (e.g., diabetic ketoacidosis) in the previous 3 months • An acute coronary or cerebrovascular event in the previous 14 days • Current continuous renal replacement therapy • End-stage liver disease • Chronic heart failure NYHA IV • A prior solid organ transplant or awaiting solid organ transplant • Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) • Personal history of non-familial medullary thyroid carcinoma • Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Subjects with intraepithelial squamous cell carcinoma of the skin (Bowen’s disease) treated with topical 5-fluorouracil (5FU) and subjects with basal cell skin cancer are allowed to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of treatment with liraglutide compared to placebo for at least 3.5 year and up to 5 years on the incidence of cardiovascular events, as defined by the below primary and secondary endpoints, in adults with type 2 diabetes that are at high risk for cardiovascular events;Secondary Objective: To assess the efficacy and safety with regard to clinically important events or other surrogate parameters of treatment with liraglutide compared to placebo in adults with type 2 diabetes that are at high risk for cardiovascular events ;Primary end point(s): Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed