Novo Nordisk’s short-acting and long-acting modern insulin analogues NovoRapid (insulin aspart) and Levemir (insulin detemir) have significantly reduced severe hypoglycaemia in people with type 1 diabetes compared to human insulin (regular/NPH), according to data from the HypoAna study published in The Lancet Diabetes & Endocrinology.
Hypoglycaemia is associated with diabetes treatment and occurs when the concentration of glucose in the blood falls to an abnormally low level.
The two-year independent investigator-initiated randomised, cross-over HypoAna trial comprised 159 patients with type 1 diabetes, who had experienced two or more episodes of severe hypoglycaemia in the preceding year.
In the trial, patients were first randomised to either treatment with basal-bolus therapy with insulin detemir and insulin aspart or human (regular/NPH) insulin and later they were then moved from their original study arm to the other half way through the trial.
The trial’s primary endpoint was the number of episodes of severe hypoglycaemia defined by need for treatment assistance from others.
The HypoAna study is supported by an unrestricted grant from the Danish pharmaceutical firm Novo Nordisk.
Most of the trials are comparing the effects of human insulin with insulin analogues particularly exclude people with diabetes that are at the highest risk of severe hypoglycaemia.
The company said that this is the first clinical trial to include only people with diabetes with recurrent severe hypoglycaemia.
Data from the trial demonstrate that compared human insulin, treatment with insulin aspart and insulin detemir reduced the rate of severe hypoglycaemia by 29% resulting in an absolute rate reduction of 0.5 episodes per patient-year.
According to the company, the number of patients needed to treat with the insulin analogues to avoid one episode of severe hypoglycaemia was two patients for one year.
Nordsjællands University Hospital primary investigator Ulrik Pedersen-Bjergaard said hypoglycaemic episodes can have severe consequences for people with diabetes, potentially causing lower treatment compliance and an increased risk of long-term complications.
"The results of this study are important for helping people with type 1 diabetes and their physicians planning optimal insulin treatment regimens," Pedersen-Bjergaard said.
Both Insulin aspart and insulin detemir are indicated for the treatment of diabetes mellitus in adults, adolescents, for diabetes in pregnancy and children aged two years and above.