Insulin Glargine 300 U/mL Therapy in Children and Adolescents with Type 1 Diabetes

Plain Language Summary The smooth and prolonged activity of insulin glargine 300 Units/mL (Gla-300), a second-generation basal insulin, results in a stable and sustained glycaemic control while allowing flexible dosing times. In children aged >= 6 years and adolescents with type 1 diabetes mellitus (T1DM), Gla-300 provides a glycaemic control comparable to that of glargine 100 Units/mL (Gla-100), a standard of care in patients with T1DM. Gla-300 and Gla-100 show similar safety profiles, with Gla-300 resulting in a clinically relevant trend towards a lower incidence of hyperglycaemia with ketosis and a lower incidence and event rate of severe hypoglycaemia in children and adolescents with T1DM. Overall, these two insulins are similar, but not interchangeable. To the best of our knowledge, only one real-world study has addressed the effectiveness and safety of Gla-300 compared to Gla-100 in newly diagnosed T1DM paediatric patients, and it has shown the therapeutic benefits of Gla-300 in clinical practice.The pharmacokinetic and pharmacodynamic properties of the second-generation basal insulin glargine 300 Units/mL (Gla-300) may be of benefit in the treatment of type 1 diabetes mellitus (T1DM). Gla-300 provides a stable and sustained time-action profile, which is associated with glycaemic control and flexible dosing schedule. This review summarises the available evidence on the safety and efficacy of Gla-300 in children and adolescents with T1DM. Gla-300 is as effective as the first-generation basal insulin glargine 100 Units/mL (Gla-100), a standard of care for patients with diabetes in reducing HbA1c, and shows a lower risk of severe hypoglycaemia and hyperglycaemia in children and adolescents with T1DM. However, Gla-300 and Gla-100 are not bioequivalent and are not directly interchangeable. Real-world studies on patients aged 6-17 years are limited. To date, only one small study assessed the effectiveness and safety of Gla-300 versus Gla-100 in newly diagnosed T1DM paediatric patients, confirming the treatment safety and effectiveness of Gla-300 in clinical practice. Gla-300 is a longer-acting basal insulin alternative in the management of children (aged >= 6 years) and adolescents with T1DM.