A randomized clinical trial to evaluate the single-dose pharmacokinetics, pharmacodynamics, and safety of sitagliptin in pediatric patients with type 2 diabetes.
Iain P FraserNaomi D NeufeldLarry A FoxMark S KipnesTracie L MillerPhilip S ZeitlerHenry RodriguezJocelyn H GilmartinSusan J LeeJaclyn K PattersonXiujiang S LiLata MagantiWen-Lin LuoDaniel A TatosianS Aubrey StochPublished in: Pediatric diabetes (2018)
Single doses of sitagliptin as high as 200 mg were generally well tolerated in 10- to 17-year-old male and female study participants with T2DM, and a daily sitagliptin dose of 100 mg is appropriate for evaluation in Phase III safety and efficacy studies in pediatric patients with T2DM. (ClinicalTrials.gov: NCT00730275).