Proleukin® and Rapamune® in Type 1 Diabetes Mellitus (IL2-RAPA)

Hypothesis: Combination therapy with IL-2 (Proleukin®) and rapamycin (Rapamune®) is safe, and will arrest pancreatic islet β-cell destruction in subjects with new-onset T1D, thereby preserving the residual β-cell mass and improving blood glucose control.

This is a single-arm, open-label, phase I(b) study in subjects with type 1 diabetes (T1DM). There will be a three-month treatment period. There will be frequent visits for safety assessments throughout the study period. In addition, assessment of diabetes control and beta cell function will be conducted every three months through the 12 month end of the trial. This is an exploratory safety study not designed or powered to examine clinical efficacy. The sample size for this study will be 10 subjects aged 18-35 years, diagnosed with T1DM within 3-48 months prior to enrollment.