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
2018
Pharmacokinetic and pharmacodynamic profile of the sodium‐glucose co‐transporter‐2 inhibitor empagliflozin in young people with Type 2 diabetes: a randomized trial
Laffel LMB, Tamborlane WV, Yver A, Simons G, Wu J, Nock V, Hobson D, Hughan KS, Kaspers S, Marquard J. Pharmacokinetic and pharmacodynamic profile of the sodium‐glucose co‐transporter‐2 inhibitor empagliflozin in young people with Type 2 diabetes: a randomized trial. Diabetic Medicine 2018, 35: 1096-1104. PMID: 29655290, PMCID: PMC6099360, DOI: 10.1111/dme.13629.Peer-Reviewed Original ResearchConceptsType 2 diabetesG/24 hPharmacodynamic profileType 2Type 2 diabetes trialsSodium-glucose co-transporter-2 inhibitor empagliflozinMaximum observed plasma concentrationPlasma concentration-time curveSimilar exposure-response relationshipsDoses of empagliflozinSerious adverse eventsParallel-group studyUrinary glucose excretionSingle oral doseDrug-related eventsObserved plasma concentrationConcentration-time curveExposure-response relationshipAdjusted mean increaseAdverse eventsDiabetes (ACCORD) trialGlucose excretionInhibitor empagliflozinOral doseMean age