Efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes

Objectives: Degludec (IDeg; Tresiba®) is a novel basal insulin with an ultra-long, flat and stable action profile. In adults, it was demonstrated to provide more glucose-lowering effects and lower rates of hypoglycemia respect to glargine (IGlar). To date studies on childhoods´ IDeg use are scarce. Aim of this study was to assess the efficacy and the safety of IDeg in children and adolescents with type 1 diabetes (T1DM) previously treated with IGlar. Methods: Twenty children and adolescents with T1DM (15.1 4.0 yrs; 9 males; 7 prepubertal; T1DM duration 7.2 3.7 yrs; IGlar treatment at least 1 year) were recruited in the study and shifted to IDeg once daily. Anthropometric (BMI-SDS), metabolic [HbA1c, FPG, and severe hypoglycaemia rates], and insulin dose [IGlar or IDeg plus short-acting or regular] were collected at baseline (T0, during IGlar treatment), 3 months (T1), and 6 months (T2) after IDeg was started. Data were analysed according to pubertal status. Results: BMI-SDS did not change on IDeg both in prepubertal and in pubertal patients. Despite HbA1c values were not significantly improved during IDeg treatment (ΔHbA1c T0-T1 -0.3%, p = 0.1; T0-T2 -0.1%, p = 0.6), FPG was significantly decreased at T1 (−18.6 34.1 mg/dl, p = 0.05). No episode of severe hypoglycaemia was reported on IDeg. We found a significant reduction in doses of both basal insulin (IGlar vs. IDeg: 21.8 8.9 vs. 19.4 7.8 IU/day, p = 0.003) and short-acting or regular mealtime insulin (T0 vs. T2 0.56 0.13 vs. 0.50 0.15 IU/kg/day, p = 0.02). Conclusions: In our patients, IDeg seems effective to improve the glycemic control reducing FPG even at lower basal insulin doses compared to IGlar. Moreover, it allowed the reduction of the dose of mealtime insulin. No episode of acute complication was reported suggesting how IDeg may be consider safe also in childhood.