The proposed mechanism of action of AG019, Lactococcus lactis bacteria delivering the human type 1 diabetes autoantigen proinsulin (hPINS) and human IL-10 (hIL-10) directly to the intestinal mucosa, is to re-educate immune cells towards antigen-specific tolerance without systemically impacting the natural protective functions of the peripheral immune system. This evidence concerns the gene INS and type 1 diabetes mellitus.