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
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
2010
STAR 3 Randomized Controlled Trial to Compare Sensor-Augmented Insulin Pump Therapy with Multiple Daily Injections in the Treatment of Type 1 Diabetes: Research Design, Methods, and Baseline Characteristics of Enrolled Subjects
Davis SN, Horton ES, Battelino T, Rubin RR, Schulman KA, Tamborlane WV. STAR 3 Randomized Controlled Trial to Compare Sensor-Augmented Insulin Pump Therapy with Multiple Daily Injections in the Treatment of Type 1 Diabetes: Research Design, Methods, and Baseline Characteristics of Enrolled Subjects. Diabetes Technology & Therapeutics 2010, 12: 249-255. PMID: 20210562, PMCID: PMC2883476, DOI: 10.1089/dia.2009.0145.Peer-Reviewed Original ResearchConceptsMultiple daily injectionsContinuous subcutaneous insulin infusionType 1 diabetesPercentage of subjectsPump therapyEnd pointBaseline characteristicsDaily injectionsKey safety end pointsType 1Sensor-Augmented Pump TherapyReal-time continuous glucose monitoringSensor-Augmented Insulin Pump TherapyNormal glycemic rangeTertiary end pointPrimary end pointSafety end pointSecondary end pointsInsulin pump therapySubcutaneous insulin infusionYears of treatmentContinuous glucose monitoringMDI cohortSevere hypoglycemiaClinical outcomes