The pharmacokinetics and pharmacodynamics of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus

• DOI: 10.1007/s00228-016-2175-1
• Publication Date: 2016-12-20T10:29:23Z
• Authors: Caroline Dudkowski; Max Tsai; Jie Liu; Zhen Zhao; Eric Schmidt; Jeannie Xie
• Keywords: Alogliptin; Pharmacodynamics

The aim of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) a single 12.5- or 25-mg dose alogliptin, dipeptidyl peptidase-4 (DPP-4) inhibitor, in pediatric (children adolescents) adult subjects with type 2 diabetes mellitus (T2DM). A randomized, open-label, multicenter was conducted subjects. Subjects two groups were randomized 1:1 receive oral alogliptin 12.5 25 mg, respectively; all gender- race-matched received mg. Blood urine samples collected at prespecified time points for PK/PD analyses. model developed using data from steady-state simulations. Safety also assessed. In receiving dose, mean peak plasma concentrations (Cmax) AUC0-inf values 26 23% lower, respectively, than adults but maximum observed DPP-4 inhibition effect (Emax) AUEC0–24 similar those adults. 12.5-mg Cmax 58 54% adults, hence Emax lower by 11 17%, respectively. simulated consistent results. No safety concern found. achieved exposures T2DM patients without concerns; therefore, recommended phase 3 trial.