Population Pharmacokinetic (PK) and Exposure-Response (ER) Analysis of Empagliflozin in Pediatric Patients with Type 2 Diabetes Mellitus (T2DM)

Presented at ACoP14. Empagliflozin, effective for type 2 diabetes in adults and children, underwent Study 1218.91 to assess its safety and efficacy over 26 weeks (with potential extension to 52 weeks) in children and adolescents. Using pediatric data from this study, researchers re-evaluated empagliflozin’s models in a Bayesian framework. Results showed similar drug exposure between children and adults at a 10 mg dose. At week 26, pediatric patients displayed a slightly larger but variable decrease in A1c compared to adults. This Bayesian method allowed insights into empagliflozin’s effects in children, drawing from knowledge gained in adult studies.