INS and type 1 diabetes mellitus: In a phase I trial, a single dose of insulin-β-chain in IFA was administered intramuscularly to patients with type 1 diabetes.143 Treatment was well tolerated and appeared to stimulate robust antigen-specific regulatory T cell populations in the treatment arm up to 24 months, although there was no statistically significant difference in mixed meal stimulated c-peptide responses compared with the control group.