The DEVOTE trial was a long-term, randomized, double-blinded and event-driven study (n=7,637) that enrolled patients with type 2 diabetes at high risk of major cardiovascular events (MACE) that were treated for about 2 years.
The study’s primary endpoint was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. The primary endpoint was met as it showed non-inferiority of MACE with Tresiba vs. insulin glargine U100 (hazard ratio 0.91). In addition, there was no statistically significant difference between the two treatments.
Treatment with Tresiba resulted in a similar HbA1c reduction (baseline 8.4%) compared to insulin glargine U100 with a 0.01% treatment difference at the end of the trial; this met the requirements for comparing hypoglycemia rates between the two arms.
Regarding the secondary confirmatory endpoint of severe hypoglycemia, the Tresiba group had 27% fewer patients experiencing an episode of severe hypoglycemia. This translated to a 40% overall reduction of total episodes of adjudicated severe hypoglycemia. Moreover, patients in the Tresiba group had a 54% relative reduction in the rate of nocturnal severe hypoglycemia. Differences between the treatment arms were all statistically significant.
These results confirmed findings from the DEVOTE interim analysis submitted to the Food and Drug Administration (FDA) in March 2015.
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