COPENHAGEN — Novo Nordisk said new data showed that its basal insulin analog is just as effective as human basal insulin in Type 1 diabetes patients ages 2 to 5 years.
According to clinical data published in Pediatric Diabetes, among a sub-group analysis of a full cohort of children ages 2 to 16 years — the full cohort is expected to be published in a relevant journal later this year — children ages 2 to 5 years treated with Levemir and a fast-acting insulin analog, NovoRapid (insulin aspart), experienced a lower rate of hypoglycemia, compared with those taking human basal insulin and NovoRapid.
Although no statistical analysis has been conducted due to the low number of patients in this age group, the hypoglycemic risk differences follow the same patterns that were revealed in the overall cohort in which differences proved to be statistically significant, the drug maker said.
No basal insulin analog currently is recommended for children in this age group, Novo Nordisk noted. It also added that it now is working to update the Levemir label.
”If our application for a label update is successful, Levemir will be the first basal insulin analog with an indication extended to this very young patient population. It will also be the second Novo Nordisk insulin analog after NovoRapid that will cover this group," said Kirstine Brown Frandsen, corporate VP global medical affairs at Novo Nordisk. "We believe this confirms our long-term commitment to developing treatments for all patients with improved safety profile.”