Phase III SWITCH1 trial of Tresiba (insulin degludec) meets endpoint in type 1 diabetes- Novo Nordisk

Novo Nordisk announced the headline results from SWITCH 1, the second of two 2x32-weeks randomised, double-blind, cross-over, treat-to-target trials, comparing the safety and efficacy of Tresiba (insulin degludec) and Lantus (insulin glargine U100). The overall purpose of the trial was to compare the hypoglycaemia occurrence in people with type 1 diabetes treated with Tresiba or insulin glargine. The primary end-point of the trial was the number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes during the maintenance period (ie after 16 weeks of treatment) in each treatment period.

From a mean baseline of 7.6%, the trial showed non-inferiority in HbA1c reduction for Tresiba compared to insulin glargine, thus fulfilling the requirements for objectively comparing hypoglycaemia rates between the two treatments. Likewise, the end-of-trial insulin doses were similar at the end of treatment in the two treatment periods. The trial met the primary end-point by demonstrating non-inferiority in the rate of severe or blood glucose confirmed symptomatic hypoglycemia of Tresiba compared to insulin glargine. The observed rate was 2,201 events per 100 patient years exposed to Tresiba and 2,463 events per 100 patient years exposed to insulin glargine during the maintenance period, corresponding to a statistically significant reduction of 11%.

Similarly, non-inferiority was demonstrated for the rate of severe or blood glucose confirmed symptomatic nocturnal hypoglycaemia in the maintenance period. The observed rate of severe or blood glucose confirmed symptomatic nocturnal hypoglycaemia was 277 events per 100 patient years exposed to Tresiba and 429 events per 100 patient years exposed to insulin glargine, corresponding to a statistically significant 36% reduction with Tresiba compared to insulin glargine. Finally, superiority was demonstrated for the confirmatory secondary endpoint of proportions of subjects experiencing severe hypoglycaemia during the maintenance period. Tresiba appeared to have a safe and well-tolerated profile.

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.