Tresiba gains FDA approval for use in children and adolescents
Lisa Foster-McNulty, MSN, RN, CDE
First approved in September of 2015 for improving blood glucose control in adults with diabetes, Tresiba is a once-daily, long-acting basal insulin, and it can now be used in children and adolescents with diabetes. This makes Tresiba the only basal insulin approved for use in both Type 1 and Type 2 in patients as young as one year old. Tresiba is released over time, with a 25 hour half-life and a consistently flat and stable profile at steady state.
The BEGIN Young 1 trial was a multi-national phase 3b trial, 26 weeks in length. It was a randomized, controlled, open-label, parallel-group, treat-to-target non-inferiority trial with a 26 week extension. Novo Nordisk submitted the supplemental New Drug Application based upon the results of this trial. It compared the safety and efficacy of once-daily Tresiba compared to Levemir (insulin detemir) administered once-daily or twice-daily, both in combination with Novolog (insulin aspart) as the rapid-acting insulin. This was done in children and adolescents with Type 1 diabetes aged 1 to 17 years. Trial results demonstrated that Tresiba in combination with Novolog was effective in improving blood glucose control. Infection, hypoglycemia, and hyperglycemia were the most commonly occurring adverse events. Evidence from adequate and well-controlled studies in adults with Type 2 was used to support the use of Tresiba in patients with Type 2 aged 1 and older.
The once-daily basal insulin Tresiba is available in the FlexTouch pen, which is the only pre-filled insulin pen without a push-button extension. The 100 U/mL pen can deliver up to 80 units of insulin in one-unit increments in a single injection; the 200 U/mL pen can deliver up to 160 units of insulin in two-unit increments in a single injection.
Tresiba is not recommended for pediatric patients who require less than 5 units of Tresiba. Children under the age of 1 were not studied, so it is unknown if Tresiba is safe and effective in this group. In a pediatric patient, if a dose of Tresiba is missed, call your healthcare provider for information and instructions. Blood sugar levels should be checked more often until the next scheduled dose of Tresiba.
The Tresiba Instant Savings Card can be used by eligible patients with commercial insurance to decrease co-pays to as low as $15 per month for up to 24 months. For terms and conditions, and for questions regarding eligibility, call 1-855-834-3466 or visit https://www.tresiba.com/instant-savings-card/eligibility.html .