FDA: Application Submitted for CV Safety Data Review of Insulin Degludec

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FDA will review data from the DEVOTE study, a long-term, randomized, double-blind, parallel group clinical trial.
FDA will review data from the DEVOTE study, a long-term, randomized, double-blind, parallel group clinical trial.

Novo Nordisk announced the submission of a supplemental application to the Food and Drug Administration (FDA) which includes data from the DEVOTE (A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes At High Risk of Cardiovascular Events; ClinicalTrials.gov identifier: NCT01959529) study, a trial that assessed the cardiovascular safety of Tresiba® (insulin degludec).

The long-term, multicenter, multinational, randomized, double-blind, parallel group, event-driven trial was conducted to confirm the cardiovascular safety of Tresiba vs insulin glargine U-100. The primary endpoint was defined as the major cardiovascular events (MACE) composite outcome of first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. In the trial, Tresiba showed non-inferiority of MACE compared to insulin glargine U-100 (hazard ratio [HR]: 0.91) with no statistically significant difference between the 2 treatment arms. 

The study also showed a similar decrease in HbA1c from baseline with Tresiba vs insulin glargine U-100 (treatment difference: 0.01 percentage points), thus meeting the requirements for objectively comparing hypoglycemia rates between the 2 treatments. Regarding severe hypoglycemia, 27% fewer patients in the Tresiba group had an episode of severe hypoglycemia, which led to a 40% overall rate reduction of total episodes of adjudicated severe hypoglycemia. The rate of nocturnal severe hypoglycemia was also reduced by 54%; these were all statistically significant. 

Tresiba is available as 3mL FlexTouch pens in 5-count cartons of U-100 and 3-count cartons of U-200.


Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba® label [news release]. Bagsværd, Denmark: Novo Nordisk. https://globenewswire.com/news-release/2017/05/27/999434/0/en/Novo-Nordisk-submits-application-in-the-US-for-including-data-from-the-DEVOTE-trial-in-the-Tresiba-label.html. Published May 27, 2017. Accessed June 16, 2017. 

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