2025
A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus
Peng X, Klingensmith G, Hsia D, Xie Y, Czerniak R, Tamborlane W, Shah A. A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus. Diabetes Therapy 2025, 1-19. PMID: 40032809, DOI: 10.1007/s13300-025-01700-3.Peer-Reviewed Original ResearchType 2 diabetes mellitusAlogliptin treatmentEfficacy endpointPediatric patientsAntihyperglycemic therapyOral dipeptidyl peptidase-4 inhibitorHbA1c levelsRandomized phase 3 studyDipeptidyl peptidase-4 inhibitorsSafety of alogliptinPlacebo-controlled trialPhase 3 studyBaseline to weekPeptidase-4 inhibitorsBody mass indexImprove glycemic controlDouble-blindPlacebo groupSecondary endpointsBackground metforminSchedule APharmacological therapyMass indexGlycosylated hemoglobinInsulin therapy
2022
Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study
Tamborlane WV, Laffel LM, Shehadeh N, Isganaitis E, Van Name M, Ratnayake J, Karlsson C, Norjavaara E. Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study. The Lancet Diabetes & Endocrinology 2022, 10: 341-350. PMID: 35378069, PMCID: PMC10851108, DOI: 10.1016/s2213-8587(22)00052-3.Peer-Reviewed Original ResearchConceptsType 2 diabetesPlacebo-assigned participantsPrespecified sensitivity analysisSafety of dapagliflozinPhase 3 studyBetween-group differencesAdverse eventsPrimary outcomeProtocol populationTreat analysisYoung adultsWeek double-blind periodRandomised phase 3 studyDouble-blind periodSerious adverse eventsNew safety signalsOral dapagliflozinDiabetic ketoacidosisSevere hypoglycaemiaMean ageTreatment optionsCare treatmentParallel groupSafety signalsStudy personnel
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