BRUSSELS (dpa-AFX) - Novo Nordisk said that the Committee for Medicinal Products for Human Use or CHMP, under the European Medicines Agency (EMA), has endorsed an update of the EU label with immediate effect for Tresiba (insulin degludec) to include results from the DEVOTE trial on severe hypoglycaemia. DEVOTE is a randomised, multinational and double-blinded 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 trial, the primary endpoint was achieved by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba compared to insulin glargine U100. Severe hypoglycaemia was evaluated as a secondary endpoint and 27% fewer patients in the Tresiba treated group experienced 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 group experienced a 53% relative reduction in the rate of nocturnal severe hypoglycaemia. These differences were all statistically significant.
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