Lagarde WH, Courtney KL, Reiner B, et al. - In this randomized, placebo‐controlled proof‐of‐concept study, researchers tested the safety, tolerability, and effectiveness of intravenous (IV) alpha ₁ ‐proteinase inhibitor [human] (Prolastin‐C) {alpha ₁‐PI[h]} in preserving C‐peptide production in newly diagnosed type 1 diabetes mellitus (T1DM) patients. They assessed four dosing regimens of alpha ₁‐PI[h]: weekly IV infusions of either 90 or 180 mg/kg, each for either 13 or 26 weeks. All groups showed highly variable declines in the primary outcome measure at 52 weeks with no statistically significant difference from placebo. Findings suggested that pharmacologic therapy with alpha ₁‐PI[h] is safe, well-tolerated, and effective in lowering IL6 levels, however, its effects on preservation of C‐peptide production were inconclusive due to variability in the efficacy endpoint.