Novo Nordisk recently announced that the US Food and Drug Administration (FDA) has 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. 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 compared to insulin glargine U-100.

Blood sugar control between the 2 groups was similar at baseline and throughout the trial. In DEVOTE, severe hypoglycemia was defined as having a low blood sugar level that requires assistance from another person to treat.