Novo Nordisk Limited

In Section  5.1  Pharmacodynamic properties, has been updated to include this Clinical data.

Other clinical data

In an open label study comparing the efficacy and safety of Victoza (1.2 mg and 1.8 mg) and sitagliptin (a DPP-4 inhibitor, 100 mg) in patients inadequately controlled on metformin therapy (mean HbA_1c 8.5%), Victoza at both doses was statistically superior to sitagliptin treatment in reducing HbA_1c after 26 weeks (‑1.24%, ‑1.50% vs ‑0.90%, p<0.0001). Patients treated with Victoza had a significant decrease in body weight compared to that of patients treated with sitagliptin (‑2.9 kg and ‑3.4 kg vs ‑1.0 kg, p<0.0001). Greater proportions of patients treated with Victoza experienced transient nausea vs subjects treated with sitagliptin (20.8% and 27.1% for liraglutide vs. 4.6% for sitagliptin). The reductions in HbA_1c and superiority vs sitagliptin observed after 26 weeks of Victoza treatment (1.2 mg and 1.8 mg) were sustained after 52 weeks of treatment (‑1.29% and ‑1.51% vs ‑0.88%, p<0.0001). Switching patients from sitagliptin to Victoza after 52 weeks of treatment resulted in additional and statistically significant reduction in HbA_1c (‑0.24% and ‑0.45%, 95% CI: ‑0.41 to ‑0.07 and -0.67 to ‑0.23 ) at week 78, but a formal control group was not available.

Date In Section 10 is: 04/2012

In section 5.1 (Pharmacodynamic Properties) Clinical data has been added

Other clinical data

In an open label study comparing the efficacy and safety of Victoza 1.8 mg once daily and exenatide 10 mcg twice daily in patients inadequately controlled on metformin and/or sulphonylurea therapy (mean HbA_1c 8.3%), Victoza was statistically superior to exenatide treatment in reducing HbA_1c after 26 weeks (–1.12% vs –0.79%; estimated treatment difference: –0.33; 95% CI –0.47 to –0.18). Significantly more patients achieved HbA_1c below 7% with Victoza compared with exenatide (54.2% vs 43.4%, p=0.0015). Both treatments resulted in mean body weight loss of approximately 3 kg. Switching patients from exenatide to Victoza after 26 weeks of treatment resulted in an additional and statistically significant reduction in HbA_1c (-0.32%, 95% CI: -0.41 to -0.24) at week 40, but a formal control group was not available. During the 26 weeks, there were 12 serious events in 235 patients (5.1%) using liraglutide, whereas there were 6 serious adverse events in 232 patients (2.6%) using exenatide. There was no consistent pattern with respect to system organ class of events.

The change concerns an update of the product information to include the term ‘urticaria’ in section 4.8 describing spontaneous reports, reflecting postmarketing surveillance reports and a recommendation by the internal Victoza^â safety committee.