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

ABSTRACT:

Background

While circulating levels of alpha₁ -proteinase inhibitor (alpha₁ -PI) are typically normal, antiprotease activity appears to be compromised in patients with Type 1 diabetes mellitus (T1DM). Because alpha₁ -PI [human] (alpha₁ -PI[h]) therapy can inhibit pro-inflammatory mediators associated with β-cell destruction and reduced insulin production, it has been proposed for T1DM disease prevention. The aim of this study was to evaluate safety, tolerability, and efficacy of intravenous (IV) alpha₁ -PI[h] in preserving C-peptide production in newly diagnosed T1DM patients.

Participants

Seventy-six participants (aged 6-35 years) were randomized at 25 centers within 3 months of T1DM diagnosis.

Methods

A Phase II

SUBMITTER: Lagarde WH 

PROVIDER: S-EPMC7984376 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature