2022
Once-Weekly Exenatide in Youth With Type 2 Diabetes
Tamborlane WV, Bishai R, Geller D, Shehadeh N, Al-Abdulrazzaq D, Vazquez EM, Karoly E, Troja T, Doehring O, Carter D, Monyak J, Sjöström CD. Once-Weekly Exenatide in Youth With Type 2 Diabetes. Diabetes Care 2022, 45: 1833-1840. PMID: 35679098, PMCID: PMC9346995, DOI: 10.2337/dc21-2275.Peer-Reviewed Original ResearchConceptsType 2 diabetesEfficacy end pointWeekly exenatideAdverse eventsPlacebo groupPrimary efficacy end pointSecondary efficacy end pointsEnd pointMetformin monotherapyTreatment of youthInsulin therapyWeek 24Pediatric patientsWeekly injectionsDaily injectionsGlycated hemoglobinCurrent treatmentExenatideBody weightDiabetesLiraglutideWeeksHemoglobinTreatmentBaselineEfficacy 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
2018
Adolescent type 2 diabetes: Comparing the Pediatric Diabetes Consortium and Germany/Austria/Luxemburg Pediatric Diabetes Prospective registries
Klingensmith GJ, Lanzinger S, Tamborlane WV, Hofer SE, Cheng P, de Beaufort C, Gal RL, Reinehr T, Kollman C, Holl RW. Adolescent type 2 diabetes: Comparing the Pediatric Diabetes Consortium and Germany/Austria/Luxemburg Pediatric Diabetes Prospective registries. Pediatric Diabetes 2018, 19: 1156-1163. PMID: 29923263, DOI: 10.1111/pedi.12712.Peer-Reviewed Original ResearchConceptsDiabetes durationClinical characteristicsBody mass index SDSAdolescent type 2Onset of T2DPediatric Diabetes ConsortiumShorter diabetes durationMost recent visitType 2 diabetesYears of ageProspective registryTreatment of youthAdverse eventsDiabetes complicationsHigher HbA1cOffice visitsHigher hemoglobinUnited States databaseVs 3.2Diabetes testingType 2RegistryLaboratory dataTreatment differencesFurther studiesPharmacokinetic 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
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
2012
A Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes
Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan D, Tollefsen S, Wilfley D, Kaufman F. A Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes. New England Journal Of Medicine 2012, 366: 2247-2256. PMID: 22540912, PMCID: PMC3478667, DOI: 10.1056/nejmoa1109333.Peer-Reviewed Original ResearchConceptsType 2 diabetesDurable glycemic controlGlycated hemoglobin levelsGlycemic controlLifestyle interventionPrimary outcomeHemoglobin levelsRecent-onset type 2 diabetesIntensive lifestyle interventionSerious adverse eventsLifestyle intervention programAddition of rosiglitazoneNon-Hispanic black participantsHalf of childrenYears of ageAdverse eventsPatients 10Prespecified analysisMetabolic decompensationRate of failureTreatment regimensClinical trialsMetforminType 2Rosiglitazone
2008
Insulin Glargine Versus Intermediate-Acting Insulin as the Basal Component of Multiple Daily Injection Regimens for Adolescents with Type 1 Diabetes Mellitus
Chase HP, Arslanian S, White NH, Tamborlane WV. Insulin Glargine Versus Intermediate-Acting Insulin as the Basal Component of Multiple Daily Injection Regimens for Adolescents with Type 1 Diabetes Mellitus. The Journal Of Pediatrics 2008, 153: 547-553.e3. PMID: 18589448, DOI: 10.1016/j.jpeds.2008.04.063.Peer-Reviewed Original ResearchConceptsInsulin glargineMultiple daily injectionsMultiple daily injection regimensType 1 diabetes mellitusBaseline A1C valuesDaily insulin glargineParallel group comparisonIntermediate acting insulinIntermediate-acting insulinOccurrence of hypoglycemiaPrandial insulin lisproOverall mean changeElevated A1C.MDI regimenMDI regimensBaseline A1CInjection regimensWeek 24Adverse eventsDiabetes mellitusHemoglobin A1cPediatric patientsSevere hypoglycemiaDaily injectionsA1C values
2004
A Randomized, Prospective Trial Comparing the Efficacy of Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections Using Insulin Glargine
Doyle (Boland) E, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A Randomized, Prospective Trial Comparing the Efficacy of Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections Using Insulin Glargine. Diabetes Care 2004, 27: 1554-1558. PMID: 15220227, DOI: 10.2337/diacare.27.7.1554.Peer-Reviewed Original ResearchConceptsTotal daily insulin doseMultiple daily injectionsType 1 diabetesWeeks of therapyGlargine groupDaily injectionsInsulin aspartMDI treatmentShort-term studiesContinuous subcutaneous insulin infusion (CSII) therapySubcutaneous insulin infusion therapyContinuous subcutaneous insulin infusionSelf-monitoring blood glucoseDaily insulin doseSelf-monitored blood glucose measurementsInsulin infusion therapySubcutaneous insulin infusionBlood glucose readingsSelf-monitored blood glucose readingsBlood glucose measurementsDaily glargineCSII groupDose titrationProspective trialAdverse events
2002
Insulin pump therapy in pediatrics: a therapeutic alternative to safely lower HbA1c levels across all age groups
Ahern JA, Boland EA, Doane R, Ahern JJ, Rose P, Vincent M, Tamborlane WV. Insulin pump therapy in pediatrics: a therapeutic alternative to safely lower HbA1c levels across all age groups. Pediatric Diabetes 2002, 3: 10-15. PMID: 15016169, DOI: 10.1034/j.1399-5448.2002.30103.x.Peer-Reviewed Original ResearchDiabetes programContinuous subcutaneous insulin infusion (CSII) therapySubcutaneous insulin infusion therapyDiabetes-related adverse eventsDaily insulin dosesMean HbA1c levelPrimary efficacy outcomeSevere hypoglycemic eventsPatients 18 monthsPrimary safety measureInsulin infusion therapyYr of ageEfficacy outcomesHbA1c levelsAdverse eventsInjection therapyYounger patientsPump treatmentDiabetes controlHypoglycemic eventsInsulin dosesInfusion therapyTherapeutic alternativeClinic settingClinical data