Population Pharmacokinetic and Exposure-Response Analysis of Linagliptin in Pediatric Patients with Type 2 Diabetes Mellitus

Presented at ACoP14. This study assessed linagliptin’s effectiveness and safety in children and adolescents with type 2 diabetes over 26 weeks, potentially extending to 52 weeks. The study re-evaluated models developed for adults and adolescents to understand linagliptin’s impact on pediatric patients’ HbA1c levels. Results indicated slightly higher and more varied linagliptin exposure in children compared to adults at a 5 mg dose. Although pediatric patients had a smaller and variable HbA1c reduction versus adults at week 26, the Bayesian approach helped characterize linagliptin’s effects in children based on limited data, borrowing insights from adult studies.