FDA approves inclusion of data from safety outcomes trial in the Tresiba label

Novo Nordisk announced that the US Food and Drug Administration (FDA) approved updates to the prescribing information (PI) for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcomes trial. The following data from DEVOTE in patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) is now included in the label:

• Primary composite endpoint: Tresiba U-100 demonstrated no increased risk of major adverse cardiovascular events (MACE) with a hazard ratio of 0.91 compared to insulin glargine U-100 (95% confidence interval [CI]: 0.78; 1.06, p<0.001).1 MACE in the DEVOTE trial is defined as the first occurrence of cardiovascular death, non-fatal heart attack, or non-fatal stroke.
• Secondary confirmatory endpoint: Tresiba U-100 demonstrated 40% significantly lower rates of severe hypoglycemia (low blood sugar) compared to insulin glargine U-100 (95% CI: 0.48; 0.76, p<0.001).

Blood sugar control between the two groups was similar at baseline and throughout the trial.1 In DEVOTE, severe hypoglycemia was defined as having a low blood sugar level that requires assistance from another person to treat.

“Tresiba is clinically proven to lower patients’ A1C levels, and now the updated label provides physicians with additional clinical evidence to help guide treatment decisions,” said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk. “Cardiovascular disease and severe hypoglycemia are two of the most profound concerns for people living with diabetes. Novo Nordisk is dedicated to research in these areas and believes in their importance to overall diabetes care.”