Novo Nordisk has announced new post-hoc analyses from the DEVOTE trial showing that people with type 2 diabetes at high risk of cardiovascular disease who experience severe hypoglycaemia (low blood glucose levels, requiring third party assistance) are at greater risk of death.
The risk was four-fold higher (2.78 events/100 patient-years vs 11.23 events/100 patient-years) 15 days after an event and two and a half-fold higher (2.64 events/100 patient-years vs 7.32 events/100 patient-years) anytime following an episode of severe hypoglycemia.
In addition, results also showed that daily fluctuations in blood glucose levels in people with type 2 diabetes at high risk of cardiovascular disease are associated with a higher risk of death. The results were presented at the European Association for the Study of Diabetes 53rd Annual Meeting (EASD).
In the DEVOTE trial, there was no difference in the death rate between Tresiba® (insulin degludec) and insulin glargine U100 (202 vs 221 patients; 2.67 vs 2.92 events / 100 patient-years hazard ratio 0.91; p=0.35 respectively). However, insulin degludec significantly reduced the rate of severe hypoglycaemia by 40% (3.70 events/100 patientyears with insulin degludec vs 6.25 events/100 patient-years with insulin glargine U100) and the rate of nocturnal severe hypoglycaemia by 53% (0.65 vs 1.40 events/100 patient-years) compared to insulin glargine U100 in people with type 2 diabetes.
Professor Ponnusamy Saravanan, Professor and Honorary Consultant Physician in Diabetes, Endocrinology & Metabolism, University of Warwick, said: “The heightened risk of death associated with having severe episodes make it an absolute priority to manage effectively when looking at overall diabetes care, along with maintaining target blood glucose levels. Having treatment options available that reduce the risk of severe hypoglycaemia is a reassuring clinical advancement.”
Dr Avideh Nazeri, Director of Clinical, Medical and Regulatory, Novo Nordisk UK said: “Being able to offer a treatment that has been proven to reduce the risk of severe hypoglycaemia compared to glargine U100 is an important achievement”.