Physicians can prescribe Tresiba to children and adolescents aged one to 17 with type I or type II diabetes.
The approval is based on efficacy and tolerability data from the BEGIN YOUNG 1 trial, which showed that insulin degludec given once daily in combination with insulin aspart (NovoRapid) maintained long-term glycaemic control in children and adolescents with type I diabetes.1
"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 investigator of BEGIN YOUNG 1.
"This [approval] for insulin degludec offers patients between the ages of one and 17 a once-daily basal insulin which allows patients to get to target with a reduced risk of hyperglycaemia with ketosis versus insulin detemir."
Efficacy and safety
The BEGIN YOUNG 1 trial was a randomised, open-label 26-week treat-to-target trial comparing the efficacy and safety of insulin degludec (given once daily), and insulin detemir (Levemir; given once or twice daily), both in combination with bolus insulin aspart in children and adolescents with type I diabetes.1
Insulin degludec met the primary endpoint of non-inferiority to insulin detemir for mean change in HbA1c at 26 weeks (p<0.05). In a 26-week extension of the trial, patients who received insulin degludec achieved a lower insulin dose and a significantly greater reduction in fasting plasma glucose than those given insulin detemir (p<0.05).
The two regimens were associated with similar rates of overall, nocturnal, and severe hypoglycaemia although patients on insulin degludec had significantly lower rates of hyperglycaemia with ketosis (p<0.05). Patients’ weight remained unchanged with insulin detemir but increased with insulin degludec. Adverse event profiles were similar for insulin degludec and insulin detemir.1
Flexible dose timing
Insulin degludec has a duration of action exceeding 42 hours, allowing flexibility in day-to-day time of administration. In patients with type II diabetes, it can be administered alone or in combination with oral antidiabetic agents (including GLP-1 receptor agonists) and bolus insulin. In type I diabetes, Tresiba must be combined with rapid-acting insulin to cover mealtime insulin requirements.
Tresiba is available in two strengths: 100 units/ml and 200 units/ml. These are delivered in two distinct FlexTouch pen devices: the light green 100 units/ml pen, which delivers insulin in one-unit steps and the dark green 200 units/ml pen, which delivers insulin in two-unit steps. Prescribers should always specify the strength of Tresiba on the prescription and patients should visually identify the strength of Tresiba they are dispensed.
- Thalange N et al. Long-term efficacy and safety of insulin degludec in combination with bolus insulin aspart in children and adolescents with type 1 diabetes. Diabetologia 2014; 57 (Suppl 1): S395.