Results from a long-term study, DEVOTE, evaluating the safety of Novo Nordisk's (NYSE:NVO) Tresiba (insulin degludec injection) compared to insulin glargine U100 when added to standard of care achieved the primary endpoint of demonstrating non-inferiority in terms of major cardiovascular events (MACE). The final results confirmed the interim data Novo submitted to the FDA in March 2015.
The study involved 7,500 type 2 diabetics at high risk of MACE who were treated for ~two years. The primary endpoint was defined as the MACE composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Participants receiving Tresiba experienced a 9% lower risk of MACE (hazard ratio = 0.91) compared to insulin glargine. There was no statistical difference between the two treatments. The reductions in HbA1c from baseline were also similar.
Fewer patients (27%) in Tresiba group experienced an episode of severe hypoglycemia and there was a 54% relative reduction in the rate of nocturnal severe hypoglycemia. The differences were statistically significant.
Detailed results from DEVOTE will be presented at a future scientific conference. The data will be submitted to regulatory authorities in H1 2017.
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