FDA to Review Cardiovascular Safety Data for Tresiba
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.
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.