Victoza® Product Monograph. Mississauga, Ontario; Novo Nordisk Canada Inc.; 17 November 2017.
Data on file [IMS], Novo Nordisk Canada Inc., November 2017.
Data on file [IMS], Novo Nordisk Canada Inc., September 2017.
Davies MJ et al. Efficacy and Safety of Liraglutide vs Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial. Diabetes Care. 2016;39(2):222-230.
A 26-week, double-blind, placebo-controlled, parallel-group trial randomized 279 patients with type 2 diabetes and moderate renal impairment (eGFR 30–59 mL/min/1.73 m2) to once-daily Victoza® 1.8 mg (n=140) or placebo (n=139) as add-on to insulin ± OADs. The primary outcome measure was change in A1C from baseline to week 26. Baseline values for Victoza® 1.8 mg (n=140) and placebo (n=137): A1C (%): 8.08 and 8.00, respectively; body weight (kg): 93.6 and 95.6, respectively.
Bailey TS et al. Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH™): a randomized, double-blind, double-dummy, active-controlled 26-week trial. Diabetes Obes Metab. 2016. doi: 10.1111/dom.12736.
A 26-week, multicentre, parallel-group, double-blind, double-dummy, active-controlled trial randomized 406 patients with type 2 diabetes, A1C 7.5–9.5%, body mass index (BMI) ≥20 kg/m2, previously treated with stable doses of sitagliptin (100 mg/day) and metformin ( ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day) for ≥90 days to once-daily Victoza® 1.8 mg + sitagliptin placebo (n=202) or sitagliptin 100mg/day + Victoza® placebo (n=204) as add-on to metformin. The primary endpoint was change in A1C from baseline to week 26. A confirmatory secondary endpoint was change in body weight from baseline to week 26. Other secondary endpoints included: subjects meeting A1C target <7.0% (ADA target); composite endpoint of subjects achieving A1C <7.0% and no weight gain. Baseline values for Victoza® 1.8 mg + sitagliptin placebo (n=202) and sitagliptin 100mg/day + Victoza® placebo (n=204): A1C (%): 8.3 and 8.2, respectively; body weight (kg): 88.9 and 91.2, respectively.
Quick Reference Guide: 2013 Clinical Practice Guidelines (updated Nov 2016). Canadian Diabetes Association. November 2016.
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. Marso SP et al. New Engl J Med. 2016. DOI: 10.1056/NEJMoa1603827.
A multicentre, international, randomized, double-blind, placebo controlled cardiovascular outcomes trial.
The trial looked at T2D patients 50 years of age and with concomitant cardiovascular, cerebrovascular, peripheral vascular disease, chronic renal failure or chronic heart failure (n=7598) or 60 years of age and other specified risk factors of vascular disease (n=1742). Patients were randomized to either Victoza® 1.8 mg once daily and standard of care (n=4668) or placebo once daily and standard of care (n=4672) with a median duration of exposure was 3.5 years and up to a maximum of 5 years.
The primary endpoint was the time from randomization to first occurrence of any major adverse cardiovascular events (MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. If non-inferiority was met for the primary endpoint, superiority was also tested.