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
2019
Liraglutide in Children and Adolescents with Type 2 Diabetes
Tamborlane WV, Barrientos-Pérez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T. Liraglutide in Children and Adolescents with Type 2 Diabetes. New England Journal Of Medicine 2019, 381: 637-646. PMID: 31034184, DOI: 10.1056/nejmoa1903822.Peer-Reviewed Original ResearchConceptsGlycated hemoglobin levelsType 2 diabetesGastrointestinal adverse eventsAdverse eventsPlasma glucose levelsHemoglobin levelsEnd pointGlycemic controlGlucose levelsMean glycated hemoglobin levelOpen-label extension periodPrimary efficacy end pointDose of liraglutideDouble-blind periodEfficacy end pointPrimary end pointSecondary end pointsBody mass indexNumber of patientsYears of ageMetformin monotherapySubcutaneous liraglutidePlacebo groupLiraglutide groupInclusion criteria