This study is a multicenter, double-blind, placebo-controlled, 2:1 randomly assigned, phase 1
clinical trial for individuals with type 1 diabetes. It is a blinded dose-ranging study
enrolling patients with new onset type 1 diabetes with documented continued residual
C-peptide production. After a 4 week screening and run-in period during which eligibility
will be determined and glycemic control optimized, subjects will have a 3-month double-masked
treatment period with either DFMO or placebo. After a 3 month wash-out period the durability
of effect will be assessed. Subjects will be randomly assigned (6 to DFMO; 3 to placebo in
each cohort) to 1 of 4 sequential dose cohorts.