The European Commission has approved expanded use of Novo Nordisk’s Tresiba (insulin degludec) to include children and adolescents with diabetes aged one to 17 years.
The green light is based on data from the BEGIN YOUNG 1 trial, to be presented later today at the Diabetes UK Professional Conference in London, showing that Tresiba given once daily in a basal-bolus regimen with insulin aspart effectively maintained long-term glycaemic control.
Tresiba is a long-acting basal insulin analogue first approved in Europe in 2013 for once-daily use in adults with both type I and type II diabetes followed by clearance in May 2014 for combination use with GLP-1 receptor agonists. Conveniently, the drug can be administered at any time of the day and, thereby, is the first to offer diabetics flexibility in the timing of taking insulin.
Real world benefits
Meanwhile, the first batch of real-world data for Tresiba has been released today which Novo says shows the drug’s value in clinical practice.
Interviews and surveys with 125 physicians across the UK, Switzerland, Sweden, Luxembourg and Germany, found include better blood glucose control (reported by 58 physicians on 1,149 patients), improved patient quality of life relating to flexibility of administration time and dosage when needed (44 physicians in 602 patients), and reduced hypoglycaemic episodes (30 physicians on 512 patients).
In addition, 41% of physicians reported a reduction in dose when switching patients to insulin degludec (51 physicians on 1,043 patients) and data show an 18% dose reduction with patients who use insulin degludec (42 physicians on 957 patients).