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
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
2016
Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes
Sherr JL, Ruedy KJ, Foster NC, Piché CA, Dulude H, Rickels MR, Tamborlane WV, Bethin KE, DiMeglio LA, Fox LA, Wadwa RP, Schatz DA, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW. Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes. Diabetes Care 2016, 39: 555-562. PMID: 26884472, PMCID: PMC4806770, DOI: 10.2337/dc15-1606.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, IntranasalAdolescentBlood GlucoseChildChild, PreschoolCohort StudiesCross-Over StudiesDiabetes Mellitus, Type 1Dose-Response Relationship, DrugDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleGlucagonHumansHypoglycemiaInjections, IntramuscularInsulinMaleNauseaPowdersConceptsIntramuscular glucagonType 1 diabetesIntranasal dosesIntranasal glucagonYounger cohortsWeight-based doseMin of dosingTreatment of hypoglycemiaDose-response relationshipTransient nauseaDl riseSevere hypoglycemiaGlucagon levelsIntranasal doseClinical centersPlasma glucosePharmacodynamic studiesHospital settingGlucagon preparationPotential efficacyGlucagonType 1Adverse effectsCohortAge range
2015
Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial
Libman IM, Miller KM, DiMeglio LA, Bethin KE, Katz ML, Shah A, Simmons JH, Haller MJ, Raman S, Tamborlane WV, Coffey JK, Saenz AM, Beck RW, Nadeau KJ. Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial. JAMA 2015, 314: 2241-2250. PMID: 26624824, DOI: 10.1001/jama.2015.16174.Peer-Reviewed Original ResearchConceptsType 1 diabetesBody mass indexGastrointestinal adverse eventsEffect of metforminTotal daily insulinGlycemic controlPlacebo groupOverweight adolescentsMetformin groupBaseline HbA1cAdverse eventsDaily insulinClinical trialsMultiple secondary end pointsOverweight/obese adolescentsSafety of metforminSecondary end pointsUse of metforminAddition of metforminBMI z-scoreMeasures of adipositySecondary outcomesBlood pressureInsulin dosePrimary outcome
2014
Glycemic control after 6 days of insulin pump reservoir use in type 1 diabetes: Results of double‐blind and open‐label cross‐over trials of insulin lispro and insulin aspart 1型糖尿病患者连续使用胰岛素泵6天后的血糖控制情况:赖脯胰岛素与门冬胰岛素的双盲、开放标签、交叉试验
Tamborlane WV, Renard E, Wadwa RP, Blevins T, Jacober SJ, Liu R, D'Souza DN, Rees TM. Glycemic control after 6 days of insulin pump reservoir use in type 1 diabetes: Results of double‐blind and open‐label cross‐over trials of insulin lispro and insulin aspart 1型糖尿病患者连续使用胰岛素泵6天后的血糖控制情况:赖脯胰岛素与门冬胰岛素的双盲、开放标签、交叉试验. Journal Of Diabetes 2014, 7: 270-278. PMID: 24734891, DOI: 10.1111/1753-0407.12162.Peer-Reviewed Original ResearchMeSH KeywordsAdultBlood GlucoseBlood Glucose Self-MonitoringChinaCross-Over StudiesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Double-Blind MethodFemaleFollow-Up StudiesHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsInsulin AspartInsulin Infusion SystemsInsulin LisproMalePostprandial PeriodPrognosisRisk FactorsConceptsContinuous subcutaneous insulin infusionSelf-monitoring blood glucoseTreatment periodCross-over designBlood glucoseDay 6Insulin aspartInsulin lisproMean total daily insulin doseTotal daily insulin doseTotal hypoglycemia rateDaily insulin dosePrimary efficacy measureType 1 DMMean blood glucoseSubcutaneous insulin infusionType 1 diabetesHypoglycemia ratesInsulin doseRandomized trialsEfficacy measuresSMBG profilesInsulin infusionDay 1Two-treatment
1993
Effect of caffeine on the recognition of and responses to hypoglycemia in humans.
Kerr D, Sherwin RS, Pavalkis F, Fayad PB, Sikorski L, Rife F, Tamborlane WV, During MJ. Effect of caffeine on the recognition of and responses to hypoglycemia in humans. Annals Of Internal Medicine 1993, 119: 799-804. PMID: 8379601, DOI: 10.7326/0003-4819-119-8-199310150-00005.Peer-Reviewed Original ResearchConceptsGlucose levelsHypoglycemic symptomsCaffeine consumptionCounter-regulatory hormone levelsHyperinsulinemic glucose clamp techniqueMiddle cerebral artery velocityLarge carbohydrate loadCerebral artery velocityAcute caffeine ingestionClinical Research CenterLevels of norepinephrineAwareness of hypoglycemiaCerebral blood flowDouble-blind designGlucose clamp techniqueLate postprandial periodPlasma glucose levelsLevels of epinephrineBrain glucose useCaffeine-free colaEffects of caffeineAcute ingestionSympathoadrenal activationArtery velocityPlasma glucose