biospaceMarch 27, 2018
Tag: FDA , Novo Nordisk
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:
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®?
Do not share your Tresiba® FlexTouch® with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Who should not take Tresiba®?
Do not take Tresiba® if you:
Before taking Tresiba®, tell your health care provider about all your medical conditions, including if you are:
Talk to your health care provider about low blood sugar and how to manage it.
How should I take Tresiba®?
What are the possible side effects of Tresiba®?
Tresiba® may cause serious side effects that can be life-threatening, including:
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