Tresiba Label Updated With Data on Severe Hypoglycemia, CV Outcomes

The Tresiba label was updated to reflect safety outcomes from the DEVOTE trial.

Novo Nordisk announced that the Food and Drug Administration (FDA) has approved an update to the prescribing information for Tresiba (insulin degludec) to include cardiovascular outcomes and severe hypoglycemia study data. 

The DEVOTE trial (N=7,637) was a multinational, double-blinded clinical trial that evaluated adults with type 2 diabetes at high cardiovascular risk over 104 weeks; all patients had inadequately controlled type 2 diabetes and atherosclerotic cardiovascular disease.

Study findings showed non-inferiority of Tresiba compared to insulin glargine U100 with regard to major adverse cardiovascular events (MACE), defined as first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (hazard ratio [HR] 0.91).

Also, Tresiba resulted in a 40% statistically significant lower rate of severe hypoglycemia when compared to insulin glargine U100.

“It is well known that the fear of severe hypoglycemia is a barrier to achieving good glycemic control for many people with diabetes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We are therefore very pleased that the FDA has approved the updated label for Tresiba as the only basal insulin to be labelled with a lower rate of severe hypoglycemia compared to insulin glargine U100.”

Tresiba, a basal insulin, is currently approved to improve glycemic control in patients with diabetes mellitus. It is available as 100U/mL and 200U/mL strengths in 3mL FlexTouch pens.

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This article originally appeared on MPR