Study shows NovoRapid® (insulin aspart) and Levemir® (insulin detemir) significantly reduce severe hypoglycaemia
Data from the independent investigator-initiated HypoAna study published in The Lancet Diabetes & Endocrinology, shows that Novo Nordisk's short-acting and long-acting modern insulin analogues NovoRapid® (insulin aspart) and Levemir® (insulin detemir) significantly reduce severe hypoglycaemia in people with type 1 diabetes compared to human insulin (regular/NPH).1
Most studies comparing the effects of human insulin with those of insulin analogues specifically exclude people with diabetes that are at the highest risk of severe hypoglycaemia.2-5 This is the first clinical trial to include only people with diabetes with recurrent severe hypoglycaemia.6
The findings show that compared to 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. The number of patients needed to treat with the insulin analogues to avoid one episode of severe hypoglycaemia was two patients for one year.1
"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", says primary investigator Ulrik Pedersen-Bjergaard, Nordsjællands University Hospital, Hillerød, Denmark
On average, one in five patients with type 1 diabetes suffer from recurrent severe hypoglycaemia and experience more than one episode of severe hypoglycaemia per year.1
"The HypoAna results reinforce the importance and value of modern insulin analogues in the treatment of diabetes. Hypoglycaemia can have a debilitating effect on the lives of people with diabetes, particularly for those who experience severe recurrent hypoglycaemia, potentially leading to hospitalisations and ongoing health problems. It is very encouraging that these new data confirm a reduction in risk of hypoglycaemia, compared to human insulin, amongst those patients, who are at highest risk. At Novo Nordisk, we've been leading the evolution in diabetes therapies for over 80 years and are committed to developing a new generation of innovative insulin therapies, with insulin degludec the most recent addition to our portfolio", says Dr Klaus Henning Jensen, Director of Clinical, Medical and Regulatory, Novo Nordisk UK.
About the HypoAna Trial
The Danish study was a two-year investigator-initiated randomised, cross-over trial including 159 patients with type 1 diabetes, who had experienced two or more episodes of severe hypoglycaemia in the preceding year. Patients were first randomised to either treatment with basal-bolus therapy with insulin detemir and insulin aspart or human (regular/NPH) insulin. Patients were then moved from their original study arm to the other half way through the trial. The study'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 Novo Nordisk.
About insulin aspart (NovoRapid®) and insulin detemir (Levemir®)
Insulin aspart is a mealtime insulin analogue while insulin detemir is a long-acting insulin analogue. Insulin aspart and insulin detemir are both indicated for the treatment of diabetes mellitus in adults, adolescents, for diabetes in pregnancy and children aged 2 years and above. Insulin aspart has been available for use in Europe since 1999 and insulin detemir since 2004. Insulin aspart is currently approved in more than 100 countries and insulin detemir in more than 75 countries worldwide.