A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Alpha-1 Antitrypsin (AAT) (Glassia®) in the Treatment of Recent-Onset Type 1 Diabetes

@article{Lebenthal2019API,
  title={A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Alpha-1 Antitrypsin (AAT) (Glassia{\textregistered}) in the Treatment of Recent-Onset Type 1 Diabetes},
  author={Yael Lebenthal and Avivit Brener and Eli Hershkovitz and Naim Shehadeh and Shlomit Shalitin and Eli C. Lewis and Dana Elias and Alon Haim and Galia Barash and Neta Loewenthal and Nehama Zuckerman-Levin and Michal Stein and Naveh Tov and Marianna Rachmiel},
  journal={International Journal of Molecular Sciences},
  year={2019},
  volume={20}
}
Our aim was to assess the efficacy, safety, and tolerability of alpha-1 antitrypsin (AAT) as a therapeutic modality for β-cell preservation in patients with recent-onset type 1 diabetes. Seventy type 1 diabetes patients (37 males; mean age 13.1 ± 4.1years) were randomized to treatment with 22 infusions of AAT (Glassia®) (60 or 120 mg/kg) or placebo. The primary outcome was the area under the curve (AUC) of C-peptide from a 2-h mixed-meal tolerance test after 52 weeks. At week 52, C-peptide was… 
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