Novo Nordisk today 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.1
- 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).1
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."
About DEVOTE
DEVOTE is a multi-national, randomized, double-blinded, treat-to-target, event-driven trial comparing Tresiba® (insulin degludec injection) U-100 to insulin glargine U-100. In the trial, 7,637 people (Tresiba® U-100: n=3,818, insulin glargine U-100: n=3,819) with inadequately controlled type 2 diabetes and atherosclerotic cardiovascular disease were randomized to once daily treatment with either Tresiba® U-100 or insulin glargine U-100 in addition to standard of care for diabetes and cardiovascular disease for a median duration of 2 years.
The primary composite endpoint in DEVOTE was time from randomization to the first occurrence of a three component composite major adverse cardiovascular event, comprised of: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Secondary endpoints included events and incidence of severe hypoglycemia.
About Tresiba®
Tresiba® is the only long-acting insulin approved for type 1 and type 2 diabetes in children as young as 1 year of age. Once-daily Tresiba® is available in Novo Nordisk's latest insulin delivery device - FlexTouch®, a 100 units/mL or 200 units/mL pen. Tresiba® U-100 FlexTouch® can deliver up to 80 units of insulin in a single injection. Tresiba® U-200 FlexTouch® can dose up to 160 units in a single injection. FlexTouch®is also the only prefilled insulin pen with no push-button extension.
Tresiba® received its first regulatory approval in Japan in September 2012 and has since been approved in more than 80 countries globally. It was approved by the FDA in the United States on September 25, 2015.
What is Tresiba®?
- Prescription Tresiba® is a long-acting insulin used to control high blood sugar in adults and children who are 1 year of age and older with diabetes
- Tresiba® is not for people with diabetic ketoacidosis
- Tresiba® is not for children who need less than 5 units of Tresiba® each day
- It is not known if Tresiba® is safe and effective in children under 1 year of age
- Tresiba® is available i...
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