The FINANCIAL — Novo Nordisk on September 23 announced the submission of a supplemental application to the US Food and Drug Administration (FDA) for including data from the two SWITCH phase 3b trials in the label for Tresiba.
In SWITCH 1, people with type 1 diabetes were randomised to cross-over treatment with Tresiba® and insulin glargine U100, respectively, both in combination with insulin aspart. During the study’s maintenance period, people treated with Tresiba® on average had 11% fewer episodes of overall symptomatic blood glucose confirmed hypoglycaemia, 36% fewer episodes of nocturnal blood glucose confirmed symptomatic hypoglycaemia and 35% fewer episodes of severe hypoglycaemia. All of the above results were statistically significant and similar results were seen in the full treatment period, according to Novo Nordisk.
In SWITCH 2, people with type 2 diabetes were randomised to cross-over treatment with Tresiba and insulin glargine U100, respectively, both in combination with oral antidiabetic drugs. During the study’s maintenance period, people treated with Tresiba on average had 30% fewer episodes of overall blood glucose confirmed symptomatic hypoglycaemia and 42% fewer episodes of nocturnal blood glucose confirmed symptomatic hypoglycaemia, both favouring Tresiba over insulin glargine U100. Both observations were statistically significant and similar results were observed for the full treatment period. For severe hypoglycaemia there was a 46%, but not statistically significant reduction of the episodes in the maintenance period, and a statistically significant 51% reduction of the episodes in the full treatment period for Tresiba compared to insulin glargine U100.
In both studies, the mean baseline for HbA1c was 7.6%, and both studies showed that Tresiba® was non-inferior in terms of HbA1c reduction compared to insulin glargine U100. This means that the requirements for objectively comparing hypoglycaemia episodes between the two treatments were fulfilled. In both studies, Tresiba generally appeared to have a safe and well-tolerated profile.
“Hypoglycaemia continues to be a real challenge for many people with type 1 and type 2 diabetes. We believe that inclusion of the SWITCH trial results in the prescribing information for Tresiba will provide healthcare professionals with important information to make an informed choice when prescribing basal insulin” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
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