Human plasma-derived alpha1 -proteinase inhibitor in patients with new-onset type 1 diabetes mellitus: a randomized, placebo-controlled proof-of-concept study.

Background While circulating levels of alpha1 proteinase inhibitor (alpha1 -PI) are typically normal, anti-protease activity appears to be compromised in patients with type 1 diabetes mellitus (T1DM). Because Alpha1 -PI[human] therapy can inhibit pro-inflammatory mediators associated with β cell destruction and reduced insulin production, it has been proposed for T1DM disease prevention. Objective To evaluate safety, tolerability and efficacy of IV Alpha1 -PI[human] in preserving C-peptide production in newly diagnosed T1DM patients. This article is protected by copyright. All rights reserved.