Tresiba Label Seeks Hypoglycemia Trial Data Inclusion

Novo Nordisk has submitted a supplemental application to the FDA to include data from the 2 phase 3b SWITCH trials in the prescribing information for insulin degludec (Tresiba), a once-daily basal insulin that provides a duration of action beyond 42 hours for patients with type 1 and type 2 diabetes.

In the SWITCH 1 trial, patients with type 1 diabetes were randomized to crossover treatment with Tresiba and insulin glargine U100, both in combination with an oral antidiabetic agent. Those treated with Tresiba had an average of 11% fewer episodes of blood glucose-confirmed symptomatic hypoglycemia. They also had 35% fewer episodes of severe hypoglycemia and 36% fewer episodes of nocturnal blood glucose-confirmed symptomatic hypoglycemia.

In the SWITCH 2 trial, patients with type 2 diabetes were randomized to crossover treatment with Tresiba and insulin glargine U100, both in combination with an oral antidiabetic agent. During the study’s maintenance period, those who were given Trebsiba had 30% fewer episodes of overall blood glucose-confirmed symptomatic hypoglycemia. They also exhibited 42% fewer episodes of nocturnal blood glucose-confirmed symptomatic hypoglycemia.

In both trials, the mean HbA1C baseline was 7.6%, and both studies showed that Tresiba was noninferior to insulin glargine U100 in terms of HbA1C reduction, meaning the requirements for objectively comparing hypoglycemia episodes between the 2 treatments were met.

“Hypoglycemia continues to be a real challenge for many people with type 1 and type 2 diabetes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, in a press release. “We believe that inclusion of the SWITCH trial results in the prescribing information for Tresiba will provide health care professionals with important information to make an informed choice when prescribing basal insulin.”