The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for expanded use of Novo Nordisk's Tresiba (insulin degludec) in children and adolescents aged 1-17 years with diabetes. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe Tresiba to children with type 1 and type 2 diabetes.

According to the International Diabetes Federation, an estimated 497,100 children are living globally with type 1 diabetes and rates of type 2 diabetes among children are also on the increase.

"When treating children and adolescents with diabetes, getting patients to target while minimising side effects is always a priority," said Dr Nandu Thalange, paediatric endocrinologist at Norfolk and Norwich University Hospital, Norwich, United Kingdom and the lead study investigator of the BEGIN YOUNG 1 trial. "This latest CHMP recommendation for Tresiba offers patients between the ages of 1 and 17 a new once-daily basal insulin which allows patients to get to target with a reduced risk of hyperglycaemia with ketosis versus insulin detemir."

The positive CHMP opinion for expanded use of Tresiba in children and adolescents is based on efficacy and tolerability data from the BEGIN® YOUNG 1 trial, which is the first study to look into the long-term safety of Tresiba in children with type 1 diabetes. Results show that Tresiba® given once daily in combination with insulin aspart effectively improved long-term glycaemic control.

Tresiba was approved in Europe in 2013 for once-daily use in adults with type 1 and type 2 diabetes as a monotherapy and in combination with oral anti diabetic (OAD) medicinal products or with mealtime insulin. In May 2014, Tresiba was approved for combination use with GLP-1 receptor agonists.

The BEGIN YOUNG 1 trial was a randomised controlled, 26-week open-label, treat-to-target trial (with a 26-week extension) investigating the efficacy and safety of Tresiba, given once daily, and insulin detemir, given once or twice daily, both in combination with bolus insulin aspart in children and adolescents with type 1 diabetes.

Tresiba met the primary endpoint of non-inferiority to insulin detemir for mean change in HbA1c (p<0.05) at 26 weeks. In the 26-week extension a lower insulin dose and a significantly greater reduction in fasting plasma glucose (FPG ) versus insulin detemir (p<0.05) was achieved. Both regimens had similar rates of overall and nocturnal hypoglycaemia, and the rate of severe hypoglycaemia was numerically higher with Tresiba plus insulin aspart. Of note, patients on Tresiba had significantly lower rates of hyperglycaemia with ketosis (p<0.05)2. Weight (measured as SD score ) increased with Tresiba and remained unchanged with insulin detemir. Adverse event profiles were similar for Tresiba and insulin detemir.

Tresiba (insulin degludec) is a once-daily basal insulin that provides an ultra-long duration of action beyond 42 hours. It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, Tresiba allows for flexibility in day-to-day dosing time when needed.

Tresiba has received regulatory approval in Argentina, Aruba, Azerbaijan, Bangladesh, Bosnia & Herzegovina, Brazil, Chile, Colombia, Costa Rica, El Salvador, the EU, Honduras, Hong Kong, Iceland, India, Israel, Japan, Kazakhstan, Lebanon, Lichtenstein, Macedonia, Mexico, Nepal, Norway, Russia, South Korea, Switzerland and the UAE.