Two Phase III trials show Tresiba (insulin degludec injection U-100) reduces hypoglycaemia versus insulin glargine U-100 in type 2 diabetes- Novo Nordisk
New findings from the two phase IIIb SWITCH trials showed that treatment with long-acting basal insulin Tresiba (insulin degludec injection U-100), from Novo Nordisk, resulted in significantly lower rates of overall, nocturnal and severe hypoglycaemia compared with insulin glargine U-100. In SWITCH 1, patients with type 1 diabetes taking Tresiba compared with insulin glargine U-100 experienced: a rate reduction of 11% in overall symptomatic blood glucose (BG) confirmed hypoglycaemic episodes a rate reduction of 36% in nocturnal BG confirmed symptomatic hypoglycaemic episodes, and a rate reduction of 35% severe hypoglycaemia during the maintenance period. All of the above analyses showed similar results in the full treatment period.
In SWITCH 2, patients with type 2 diabetes taking Tresiba compared with insulin glargine U-100 experienced a rate reduction of 30% in overall BG confirmed symptomatic hypoglycaemic episodes and a rate reduction of 42% in nocturnal BG confirmed symptomatic hypoglycaemic episodes. The above analyses showed significant results in the full treatment period. In the maintenance period, there was a trend towards lower rates of severe hypoglycaemia in favour of Tresiba vs insulin glargine U-100. In the full treatment period, a significant 51% rate reduction in severe hypoglycaemia was observed in patients receiving Tresiba vs insulin glargine U-100. Results from the SWITCH 1 and 2 trials were presented at the American Diabetes Association 76th Scientific Sessions.
Comment: Tresiba has launched in the US where it will compete with Lantus (insulin glargine), Sanofi's best selling diabetes treatment. Tresiba has advantages over Lantus: it has a longer half life and creates less hypoglycaemia - Tresiba has a 'flat and steady' doseage profile that allows patients to dose at any time of day. Sanofi has also gained US approval for Toujeo (basal insulin) a longer-acting successor to Lantus.