Tresiba® (insulin degludec) approved in the EU for treatment of children and adolescents with diabetes

Novo Nordisk, a world leader in diabetes care, announced today that the European Commission (EC) has approved the expanded use of Tresiba^® (insulin degludec) for children and adolescents with diabetes aged one to 17 years. The extension to the licence is available to patients in the UK with immediate effect.

The approval for expanded use of insulin degludec in children and adolescents is based on efficacy and tolerability data from the BEGIN^® YOUNG 1 trial, which is being presented today at the Diabetes UK Professional Conference. The BEGIN^® YOUNG 1 study is the first to look into the long-term safety of insulin degludec in children with type 1 diabetes. Results show that insulin degludec given once daily in a basal-bolus regimen with insulin aspart effectively maintained long-term glycaemic control.¹

Dr Nandu Thalange, paediatric endocrinologist at Norfolk and Norwich University Hospital, and lead study investigator for the BEGIN^® YOUNG 1 trial said: “When treating children and adolescents with diabetes, getting patients to target while minimising side effects is a key priority. However, a large proportion of younger people with diabetes are unable to achieve this effectively with current insulin options.

“Longer-acting insulins like insulin degludec, which was shown to be effective in the BEGIN^® YOUNG 1 trial, provide an additional option for treating children and adolescents with diabetes. Clinicians can be reassured that insulin degludec offers an effective treatment option for younger people with diabetes, as well as for adults in the general diabetes population.”

According to Diabetes UK, an estimated 24,000 children are living with either type 1 or type 2 diabetes in England, with 96% having type 1.² Across Europe, the rate of type 2 diabetes among children is increasing.³

“Diabetes is a growing problem but we are delighted that insulin degludec has been approved by the European Commission for use with children and adolescents with diabetes across the EU,” said Dr Klaus Henning Jensen, medical director, Novo Nordisk Ltd. “Offering a once-daily basal insulin to help patients with both type 1 and type 2 diabetes as young as one year old effectively manage their diabetes is a significant milestone in helping tackle the burden of this disease in the UK.”

Insulin degludec is a long-acting basal insulin analogue, developed by Novo Nordisk, and approved in Europe in 2013 for once‑daily use in adults with both type 1 and type 2 diabetes.⁴ In May 2014, insulin degludec was approved for combination use with GLP-1 receptor agonists.⁴

1. Thalange N, et al. Safety and efficacy of insulin degludec in children and adolescents with type 1 diabetes. Poster presented at the Diabetes UK Professional Conference, London, 2015.
2. Diabetes UK. State of the nation (England): Challenges for 2015 and beyond. Available at: www.diabetes.org.uk/Documents/About%20Us/What%20we%20say/
   State%20of%20the%20nation%202014.pdf. Last accessed Feb 2015.
3. International Diabetes Federation. Diabetes Atlas, sixth edition. The global burden. Available at: www.idf.org/sites/default/files/EN_6E_Ch2_the_Global_Burden.pdf. Last accessed Feb 2015.
4. Tresiba^® Summary of Product Characteristics. Last updated on eMC 16 February 2015. Accessed via: www.medicines.org.uk/emc/medicine/27363/SPC/Tresiba+200+units+mL+Pre-filled+Pen+%28FlexTouch%29. Last accessed February 2015.