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
2017
Randomized, double‐blind, placebo‐controlled dose‐finding study of the dipeptidyl peptidase‐4 inhibitor linagliptin in pediatric patients with type 2 diabetes
Tamborlane WV, Laffel LM, Weill J, Gordat M, Neubacher D, Retlich S, Hettema W, Hoesl CE, Kaspers S, Marquard J. Randomized, double‐blind, placebo‐controlled dose‐finding study of the dipeptidyl peptidase‐4 inhibitor linagliptin in pediatric patients with type 2 diabetes. Pediatric Diabetes 2017, 19: 640-648. PMID: 29171139, DOI: 10.1111/pedi.12616.Peer-Reviewed Original ResearchConceptsDPP-4 inhibitionDipeptidyl peptidase-4 inhibitor linagliptinType 2 diabetesInhibitor linagliptinAdult patientsPediatric patientsPlacebo-controlled dose-finding studyDrug-related adverse eventsPrimary efficacy endpointParallel-group studyWeeks of treatmentDose-finding studyDose-dependent reductionEfficacy endpointMean HbA1cAdverse eventsFPG levelsTrough levelsClinical efficacySafety profilePlasma glucosePharmacodynamic endpointsStudy populationPatientsLinagliptin