Novo Nordisk reports additional Phase III DEVOTE data of Tresiba on CV outcomes

Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) reported additional data from the Phase III DEVOTE trial in 7,637 Type II diabetics at high risk of cardiovascular (CV) disease showing that once-daily subcutaneous Tresiba insulin degludec (NN1250) plus standard of care (SOC) for about 2 years led to a rate of major adverse cardiovascular events (MACE) of CV death, non-fatal myocardial infarction (MI) or non-fatal stroke of 4.29 events per 100 patient-years vs. 4.71 events per 100 patient-years for Lantus insulin glargine plus SOC (HR=0.91, 95% CI: 0.78, 1.06, 1-sided p<0.001 for non-inferiority). The company previously reported that Tresiba plus SOC met the primary endpoint of non-inferiority to Lantus plus SOC in time to first occurrence of a MACE. Novo Nordisk conducted the trial after FDA requested additional CV data in a complete response letter for Tresiba in 2013 (see BioCentury, April 13, 2015 & Dec. 9, 2016).

Additionally, there were no significant differences between Tresiba plus SOC and Lantus plus SOC in all-cause mortality (2.67 vs. 2.92 events per 100 patient-years, HR=0.91, 95% CI: 0.76, 1.11, p=0.35), non-CV death (0.87 vs. 1.05 events per 100 patient-years, HR=0.84, 95% CI: 0.6, 1.16, p=0.28), CV death (1.8 vs. 1.88 events per 100 patient-years, HR=0.96, 95% CI: 0.76, 1.21, p=0.71), non-fatal MI (2.27 vs. 2.47 events per 100 patient-years, HR=0.85, 95% CI: 0.68, 1.06, p=0.15), non-fatal stroke (0.98 vs. 1.16 events per 100 patient-years, HR=0.9, 95% CI: 0.65, 1.23, p=0.5) or unstable angina leading to hospitalization (1.04 vs. 1.1 events per 100 patient-years, HR=0.95, 95% CI: 0.68, 1.31, p=0.74)...