FDA to Review Cardiovascular Safety Data for Tresiba

FDA will review DEVOTE trial data for inclusion in Tresiba labeling
FDA will review DEVOTE trial data for inclusion in Tresiba labeling

Novo Nordisk announced the submission of a supplemental application to the Food and Drug Administration (FDA) which includes data from the DEVOTE 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 raito [HR] 0.91) with no statistically significant difference between the two treatment arms. 

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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 two treatments. Regarding severe hypoglycemia, 27% less 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.

For more information call (800) 727-6500 or visit Tresiba.com