Dataset from Effect of Intravenous Alpha-1 Antitrypsin on Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus (ITN041AI)

The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an
anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's
normal ability to fight infection and respond to injuries) that affects the cells thought to
be involved in the development of type 1 diabetes mellitus (T1DM, T1D).

All subjects enrolled in this study have new-onset T1DM (diagnosis of T1DM within 100 days of
Visit 0; T1DM diagnosis fulfilling American Diabetes Association standard T1DM criteria). The
focus of Part I of this trial (NCT01183468) is pharmacokinetics (PK), pharmacodynamics (PD)
and safety. Upon completion of Part I, including a satisfactory safety review, enrollment in
Part II (NCT01183455, Phase II Clinical Trial) will begin.