2024
Evidence for C-Peptide as a Validated Surrogate to Predict Clinical Benefits in Trials of Disease-Modifying Therapies for Type 1 Diabetes.
Latres E, Greenbaum C, Oyaski M, Dayan C, Colhoun H, Lachin J, Skyler J, Rickels M, Ahmed S, Dutta S, Herold K, Marinac M. Evidence for C-Peptide as a Validated Surrogate to Predict Clinical Benefits in Trials of Disease-Modifying Therapies for Type 1 Diabetes. Diabetes 2024, 73: 823-833. PMID: 38349844, DOI: 10.2337/dbi23-0012.Peer-Reviewed Original ResearchBeta cell functionType 1 diabetesMeasures of beta cell functionDisease-modifying therapiesC-peptideTrials of disease-modifying therapiesClinical benefitCell functionDestruction of pancreatic beta cellsStimulated C-peptideC-peptide levelsEnd-organ complicationsProspective cohort studyAssociated with protectionEnd-organ complications of diabetesChronic autoimmune diseaseClinically meaningful outcomesClinical outcome measuresComplications of diabetesClinical trials of disease-modifying therapiesBeta cell preservationDemonstration of efficacyPancreatic beta cellsPeripheral bloodAutoimmune diseases
2023
Teplizumab and ÎČ-Cell Function in Newly Diagnosed Type 1 Diabetes
Ramos E, Dayan C, Chatenoud L, Sumnik Z, Simmons K, Szypowska A, Gitelman S, Knecht L, Niemoeller E, Tian W, Herold K. Teplizumab and ÎČ-Cell Function in Newly Diagnosed Type 1 Diabetes. New England Journal Of Medicine 2023, 389: 2151-2161. PMID: 37861217, DOI: 10.1056/nejmoa2308743.Peer-Reviewed Original ResearchConceptsC-peptide levelsB cell functionDiagnosed type 1 diabetesType 1 diabetesSecondary end pointsEnd pointsMild cytokine release syndromePeak C-peptide levelsMonoclonal antibodies to CD3Stimulated C-peptide levelsNewly diagnosed type 1 diabetesClinical type 1 diabetesCytokine release syndromePatients 8 yearsPlacebo-controlled trialPrimary end pointAntibodies to CD3Clinical end pointsAssociated with administrationPrevent disease progressionGlycated hemoglobin levelsFood and Drug AdministrationTarget glucose rangeT cellsTeplizumab
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