New Clinical trials for diabetes showed that Levemir®, Novo Nordisk basal insulin is an effective treatment for infant babies with type 1 diabetes. Currently no basal insulin is available for infants and it seems that Novo Nordisk is on way to this to update its Levemir® for the children aged from one to five years.
Dr Nandu Thalange, of the Norfolk and Norwich University Hospital, Norwich, United Kingdom Investigator for these trials expressed, “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,”
The result for these clinical trails data were satisfactory and shown that infants till age five treated with Novo Nordisk Levemir® with NovoRapid®, a acting insulin analogue produced a decreased rates and nocturnal hypoglycaemia in compared with other Human basal insulin. In these clinical trials no statistical data were recorded due to small number of patients tested. These trials were not conducted on the patients who had a sever hypoglycaemic episode.
“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,” said Dr Nandu Thalange.
The trial investigators concluded that, comparing to human basal insulin, Levemir® plus NovoRapid® is a best treatment option for very young children and is associated with reduced 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,” said program director Kirstine Brown Frandsen, corporate vice president, Global Medical Affairs at Novo Nordisk.
This clinical trial has also been published in the online version of Pediatric Diabetes with life insurance with diabetes.