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
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.
1. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial, Dr Ulrik Pedersen-Bjergaard DMSc, Peter Lommer Kristensen PhD, Prof Henning Beck-Nielsen DMSc, Kirsten Nørgaard DMSc, Hans Perrild MD, Prof Jens Sandahl Christiansen DMSc, Tonny Jensen DMSc, Prof Philip Hougaard PhD, Prof Hans-Henrik Parving DMSc, Prof Birger Thorsteinsson DMSc, Prof Lise Tarnow DMSc, The Lancet Diabetes & Endocrinology, DOI:10.1016/S2213-8587(14)70073-7, published online 2 May 2014.
2. Kølendorf K, et al. Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes. Diabet Med 2006;23:729-35.
3. Hermansen K, et al. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia 2004;47:622–9.
4. Home P, et al. Study to Evaluate the Administration of Detemir Insulin Efficacy, Safety and Suitability (STEADINESS) Study Group: Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial. Diabetes Care 2004;27:1081-7.
5. Vague P, et al. Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care 2003;26:590–6.
6. Kristensen et al. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design. BMC Endocrine Disorders 2012;12:10.