Pharmacokinetics and pharmacodynamics of empagliflozin in paediatric patients aged 10-17 years with type 2 diabetes mellitus.

ABSTRACT:

Aims

To characterize the pharmacokinetics (PK) and PK/pharmacodynamics (PD) regarding glycosylated haemoglobin (HbA_1c) lowering using the paediatric data from DINAMO and to assess differences compared with adults.

Methods

Population PK and PK/PD models previously developed for empagliflozin in adults and adolescents were re-estimated in a Bayesian framework. The PK model included 223 observations from 74 patients receiving empagliflozin 10 mg and 25 mg and the PK/PD model used 394 observations from 103 patients receiving empagliflozin (n = 52) or placebo (n = 51).

Results

Empagliflozin PK was well described by a 2-compartment model with sequential zero-order and first-order absorption, with tested covariate effects of sex, age, race and estimated glomerular

SUBMITTER: Rascher J 

PROVIDER: S-EPMC12304805 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature