INS and type 1 diabetes mellitus: Initial promising results in murine models (66–68) led to the clinical testing of oral (7–10) and intranasal insulin [(11, 12), and INITII, NCT00336674], as tolerizing protocols in subjects at risk to develop the disease [(10, 13), NCT00336674 and TN20, NCT02580877] or in recent onset T1D patients (7–9, 11) (Table 1).