INS and type 1 diabetes mellitus: Phase 2/3, randomized, parallel assignment, double-blind, placebo-controlled trial (NCT03941132) assessing efficacy and safety of Ustekinumab in T1D. Primary outcome measures include baseline changes in 2-hour MMTT-stimulated C-peptide AUC, HbA1C, insulin use, and incidence of all adverse events. The follow up period is 12 and 18 months from the first dose (61).