Supplemental application for Tresiba (insulin degludec) in hypoglycaemia submitted to FDA- Novo Nordisk

Novo Nordisk has announced the submission of a supplemental application to the FDA for including data in the label for Tresiba (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.

In the DEVOTE trial, the primary endpoint was achieved by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba compared to insulin glargine U100. The trial confirmed the results of the DEVOTE interim analysis submitted to the FDA in March 2015, on the basis of which Tresiba and Ryzodeg 70/30 were approved in the US in September 2015. From a mean HbA 1c baseline of 8.4%, the trial showed a similar reduction with Tresiba compared to insulin glargine U100 with an end-of-trial treatment difference of 0.01 percentage points between the two treatment arms, thus fulfilling the requirements for objectively comparing hypoglycaemia rates between the two treatments. In the trial, Tresiba demonstrated superiority on the secondary confirmatory endpoint of severe hypoglycaemia: 27% fewer patients in the Tresiba treated groupexperienced an episode of severe hypoglycaemia, resulting in a 40% overall rate reduction of total episodes of adjudicated severe hypoglycaemia. Furthermore, patients in the Tresiba treated groupexperienced a 54% relative reduction in the rate of nocturnal severe hypoglycaemia. These differences were all statistically significant.