2020
Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial
Danne T, Tamborlane WV, Malievsky OA, Franco DR, Kawamura T, Demissie M, Niemoeller E, Goyeau H, Wardecki M, Battelino T. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care 2020, 43: 1512-1519. PMID: 32430458, PMCID: PMC7305011, DOI: 10.2337/dc19-1926.Peer-Reviewed Original Research
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
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 ResearchMeSH KeywordsAdministration, OralAdolescentBenzhydryl CompoundsBlood GlucoseChildDiabetes Mellitus, Type 2Dose-Response Relationship, DrugFemaleGlucosidesHumansHypoglycemic AgentsMaleSodium-Glucose Transporter 2 InhibitorsConceptsType 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
Pharmacokinetics and pharmacodynamics of canagliflozin in pediatric patients with type 2 diabetes
Tamborlane WV, Polidori D, Argenti D, Di Prospero NA. Pharmacokinetics and pharmacodynamics of canagliflozin in pediatric patients with type 2 diabetes. Pediatric Diabetes 2017, 19: 649-655. PMID: 29271103, DOI: 10.1111/pedi.12626.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAge of OnsetBrazilCanagliflozinChildDiabetes Mellitus, Type 2Dose-Response Relationship, DrugFemaleHumansHypoglycemic AgentsMalePharmacokineticsUnited StatesConceptsUrinary glucose excretionCanagliflozin 100Type 2 diabetesCanagliflozin 300T2D patientsSodium-glucose cotransporter 2 inhibitorsGlucose cotransporter 2 inhibitorsPharmacodynamics of canagliflozinSingle daily doseCotransporter 2 inhibitorsTreatment of adultsBody mass indexMaximum plasma concentrationPlasma glucose levelsDose-dependent increasePlasma concentration curveDaily doseGlucose excretionPediatric patientsMass indexPlasma concentrationsRenal thresholdGlucose levelsBody weightPatientsRandomized, 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 ResearchMeSH KeywordsAdolescentAge of OnsetChildDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansLinagliptinMalePlacebosConceptsDPP-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
2011
Effectiveness of sensor‐augmented pump therapy in children and adolescents with type 1 diabetes in the STAR 3 study
Slover RH, Welsh JB, Criego A, Weinzimer SA, Willi SM, Wood MA, Tamborlane WV. Effectiveness of sensor‐augmented pump therapy in children and adolescents with type 1 diabetes in the STAR 3 study. Pediatric Diabetes 2011, 13: 6-11. PMID: 21722284, DOI: 10.1111/j.1399-5448.2011.00793.x.Peer-Reviewed Original ResearchConceptsType 1 diabetesSensor-augmented pump therapyA1C valuesSAP groupMDI groupPump therapyA1C targetsSAP therapyHyperglycemic excursionsMultiple daily injection therapyBaseline A1C valuesRisk of hypoglycemiaA1C reductionInjection therapyPediatric patientsGlycemic excursionsGlucose variabilityMDI therapyGlycemic variabilityLower AUC valuesTreatment groupsTherapyCGM studiesDiabetesAUC values
2005
Single‐ and Multiple‐Dose Pharmacokinetics of Pioglitazone in Adolescents With Type 2 Diabetes
Christensen ML, Meibohm B, Capparelli EV, Velasquez‐Mieyer P, Burghen GA, Tamborlane WV. Single‐ and Multiple‐Dose Pharmacokinetics of Pioglitazone in Adolescents With Type 2 Diabetes. The Journal Of Clinical Pharmacology 2005, 45: 1137-1144. PMID: 16172178, DOI: 10.1177/0091270005279578.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentArea Under CurveCohort StudiesDiabetes Mellitus, Type 2Dose-Response Relationship, DrugFemaleHeadacheHumansHypoglycemic AgentsMaleMetabolic Clearance RateNauseaPioglitazoneThiazolidinedionesTime FactorsConceptsMultiple-dose pharmacokineticsType 2 diabetesMultiple dosingDoses of pioglitazoneDaily dose administrationTotal serum concentrationsLast doseFirst doseSystemic exposureDose administrationSerum concentrationsBlood samplesPioglitazoneDose levelsActive metaboliteDosingDoseDiabetesPharmacokineticsAdolescentsHoursActive compoundsAdministrationDoses
1996
Co-existence of severe insulin resistance and hyperinsulinaemia in pre-adolescent obese children
Caprio S, Bronson M, Sherwin RS, Rife F, Tamborlane WV. Co-existence of severe insulin resistance and hyperinsulinaemia in pre-adolescent obese children. Diabetologia 1996, 39: 1489-1497. PMID: 8960831, DOI: 10.1007/s001250050603.Peer-Reviewed Original ResearchConceptsObese groupHyperglycaemic clampInsulin resistanceObese preadolescentsInsulin actionGlucose-stimulated insulin levelsHigher insulin infusion ratesNon-oxidative glucose metabolismGlucose uptakeDuration of obesityGroup of obeseNon-obese subjectsBeta-cell functionDevelopment of obesityEuglycaemic hyperinsulinaemic clampSevere insulin resistanceInsulin infusion rateCross-sectional analysisOnset of pubertyAbility of insulinSevere obesityObese adultsObese childrenObese subjectsInsulin levels
1994
Comparison of the metabolic effects of recombinant human insulin-like growth factor-I and insulin. Dose-response relationships in healthy young and middle-aged adults.
Boulware SD, Tamborlane WV, Rennert NJ, Gesundheit N, Sherwin RS. Comparison of the metabolic effects of recombinant human insulin-like growth factor-I and insulin. Dose-response relationships in healthy young and middle-aged adults. Journal Of Clinical Investigation 1994, 93: 1131-1139. PMID: 8132753, PMCID: PMC294058, DOI: 10.1172/jci117065.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedC-PeptideDose-Response Relationship, DrugFatty Acids, NonesterifiedGlucagonGlucoseHumansInsulinInsulin-Like Growth Factor IMiddle AgedRecombinant ProteinsConceptsRecombinant human insulin-like growth factorInsulin-like growth factorHuman insulin-like growth factorMiddle-aged subjectsC-peptideYoung subjectsBasal IGF-I levelsHealthy middle-aged subjectsGlucose uptakeGrowth factorAdverse metabolic changesFree fatty acid levelsIGF-I levelsRelative insulin deficiencyEuglycemic clamp studiesFat oxidation rateDose-response relationshipFatty acid levelsInsulin-induced stimulationMiddle-aged adultsBasal insulinInsulin deficiencyMetabolic effectsClamp studiesRhIGF
1991
SUPPRESSION OF COUNTERREGULATORY HORMONE RESPONSE TO HYPOGLYCEMIA BY INSULIN PER SE
DIAMOND M, HALLARMAN L, STARICK-ZYCH K, JONES T, CONNOLLY-HOWARD M, TAMBORLANE W, SHERWIN R. SUPPRESSION OF COUNTERREGULATORY HORMONE RESPONSE TO HYPOGLYCEMIA BY INSULIN PER SE. The Journal Of Clinical Endocrinology & Metabolism 1991, 72: 1388-1390. PMID: 2026760, DOI: 10.1210/jcem-72-6-1388.Peer-Reviewed Original ResearchMeSH KeywordsAdultDose-Response Relationship, DrugEpinephrineFemaleGlucagonGlucose Clamp TechniqueGrowth HormoneHumansHypoglycemiaInsulinMaleConceptsCounterregulatory hormone responsesHormone responseGlucose levelsNormal subjectsCounterregulatory hormone levelsResponses of epinephrineVariable glucose infusionDegree of hyperinsulinemiaHigh-dose studiesHypoglycemic clamp studiesHypoglycemic counterregulationHypoglycemic stimulusInsulin doseExogenous insulinDose studyHormone levelsGlucose infusionClamp studiesHypoglycemiaGrowth hormoneHypoglycemic plateauInsulinModulating effectOnly variableHyperinsulinemia