"Unfortunately, children with type 1 diabetes who are aged under six years have the greatest likelihood of severe hypoglycaemia and the highest risk of acute diabetes complications.(2) This is why it is especially important to examine the safety for this very young age group," says Lead Investigator Dr Nandu Thalange, of the Norfolk and Norwich University Hospital, Norwich, United Kingdom.
The pre-specified and stratified subgroup data show that children aged two to five years treated with Levemir® plus a fast-acting insulin analogue, NovoRapid® (insulin aspart), experienced a lower rate of all day and nocturnal hypoglycaemia compared to those taking human basal insulin (neutral protamine Hagedorn insulin) and NovoRapid® (24-hour: 50.6 vs 78.3 episodes per patient-year; nocturnal hypoglycaemia: 8.0 vs 17.4 episodes per patient year). Although no statistical analysis has been conducted due to the low number of patients in this age group, the hypoglycaemic risk differences follow the same patterns that were revealed in the overall cohort which differences proved to be statistically significant.(3) No patients treated with Levemir® had a severe hypoglycaemic episode, whereas there were six reported episodes in three patients treated with human basal insulin.
"This is the first randomised controlled clinical trial with basal insulin which was conducted in paediatric patients and involved a significant proportion of children under six years old with type 1 diabetes. The results suggest clinically relevant safety benefits of Levemir® for these very young patients when compared with human basal insulin," Dr Nandu Thalange continues.
In terms of glycaemic control, HbA1c was similar between treatment groups at baseline (8.2% vs 8.1%), and changed little over one year (8.1% vs 8.3%). Fasting plasma glucose was similar at baseline (8.44 vs 8.56 mmol/l) and decreased during the trial in both arms (-1.0 vs -0.45 mmol/l). Levemir® was associated with a change in weight Z score (body weight standardised for age and gender) of -0.17 whilst in case of human basal insulin the change was +0.03.
In conclusion, the study investigators report that the data demonstrate, when compared to human basal insulin, Levemir® plus NovoRapid® is an equally efficacious treatment option for very young children and is associated with less hypoglycaemic risk.
"If our application for a label update is successful, Levemir® will be the first basal insulin analogue with an indication extended to this very young patient population. It will also be the second Novo Nordisk insulin analogue after NovoRapid® that will cover this group.(4) We believe this confirms our long-term commitment to developing treatments for all patients with improved safety profile," says Kirstine Brown Frandsen, corporate vice president, Global Medical Affairs at Novo Nordisk.
The study has been published in the online edition of Pediatric Diabetes. It is a sub-group analysis of a full cohort of children at the age of 2–16 years. The full cohort is expected to be published in a relevant journal later this year.
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy.
1. Thalange, Nandu et al. Treatment with Insulin Detemir or NPH Insulin in Children aged 2-5 Years with Type 1 Diabetes Mellitus (1689). Pediatric Diabetes 2011; http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1399-5448
2. Rewers A, Chase HP, Mackenzie T, Walravens P, Roback M, Rewers M, Hamman RF, Klingensmith G: Predictors of acute complications in children with type 1 diabetes. JAMA 2002;287:2511–2518
3. Thalange et al. Diabet Med 2010; 27(suppl.1):Oral A9
4. NovoRapid® SmPC 2010