Early Metabolic Endpoints Identify Persistent Treatment Efficacy in Recent-Onset Type 1 Diabetes Immunotherapy Trials.
Michael J HallerDavid CuthbertsonBrian N BundyMark A AtkinsonWayne MooreMichael J HallerWilliam E RussellStephen E GitelmanKevan C HeroldMaria J RedondoEmily K SimsDiane K WherrettAntoinette MoranAlberto PugliesePeter A GottliebJay M SosenkoHeba M Ismailnull nullPublished in: Diabetes care (2024)
Early dynamic measures can identify a treatment effect among successful immune therapies in type 1 diabetes trials with good long-term prediction and practical sample size over a 6-month period. While external validation of these findings is required, strong rationale and data exist in support of shortening early-phase clinical trials.