Denmark-based pharmaceutical firm Novo Nordisk has reported positive results from a clinical trial (DEVOTE) of Tresiba (insulin degludec) to treat patients with type 2 diabetes.
Tresiba is being developed as once-daily basal insulin to deliver a flat and stable glucose-lowering effect with more than 42 hours of duration of action.
The insulin degludec is said to provide flexibility for day-to-day dosing time in cases with a lack of possibility for administration at the same time of day.
The results showed that Tresiba has minimised the rate of severe hypoglycaemia by 40% and the nocturnal severe hypoglycaemia rate by 53% when compared to insulin glargine U100.
The multinational, double-blinded DEVOTE trial evaluated the cardiovascular safety of Tresiba in more than 7,500 patients over a period of 104 weeks.
DEVOTE is a cardiovascular outcomes trial (CVOT) and enrolled subjects who had a high risk of or existing cardiovascular disease and were on standard-of-care treatment given to mitigate the cardiovascular risk.
The trial indicated that Tresiba does not increase cardiovascular risk compared to insulin glargine U100.
DEVOTE Steering Committee member Dr Bernard Zinman said: "Episodes of severe hypoglycaemia are not only distressing for patients and potentially dangerous, they are also associated with an increased risk of death.
"These results highlight the importance of maintaining low variability in blood sugar levels and reducing the risk of severe hypoglycaemia when treating people with type 2 diabetes."
The trial further demonstrated that type 2 diabetes patients with severe hypoglycaemia are at greater risk for death, while daily blood sugar level fluctuations in such patients are also associated with a higher death risk.