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 diseasesComparisons of Metabolic Measures to Predict T1D vs Detect a Preventive Treatment Effect in High-Risk Individuals
Sims E, Cuthbertson D, Jacobsen L, Ismail H, Nathan B, Herold K, Redondo M, Sosenko J. Comparisons of Metabolic Measures to Predict T1D vs Detect a Preventive Treatment Effect in High-Risk Individuals. The Journal Of Clinical Endocrinology & Metabolism 2024, 109: 2116-2123. PMID: 38267821, PMCID: PMC11244203, DOI: 10.1210/clinem/dgae048.Peer-Reviewed Original ResearchSix-month changesPrevention trialsC-peptidePredicting diabetesMetabolic endpointsPreventive treatment effectsMetabolic measuresEffect of disease-modifying therapiesProportional hazards regressionTreatment effectsResponse to immunotherapyMeasurement of glucoseNatural history studiesPrevention StudyHazards regressionInclusion criteriaDisease-modifying therapiesT1D prevention trialsComparing placeboTreatment armsTeplizumabTrialNet PathwayHigh riskDetect treatment effectsCombined glucose