A Research Trial of Aralast in New Onset Diabetes (RETAIN)

Researchers are interested in conducting this study to assess whether Aralast NP (AAT, Alpha-1 Antitrypsin ) will help slow the progression of T1DM. Part I of this study has two parts:-1a and -1b: Part 1a (Complete): An open-label, dose-escalation, PK, PD and safety study. Participants receive 12 intravenous (IV) infusions of Aralast NP. Infusions 1 through 6 are administered at 45 mg/kg/wk and infusions 7 through 12 are administered at 90 mg/kg/wk. Part Ia consists of two groups: * Subjects aged 16 - 35 years at enrollment with new-onset T1DM * Subjects aged 8 -15 years at enrollment with new-onset T1DM. Part 1b (study terminated prior to subject enrollment): An open-label, dose-escalation PK, PD and safety study in which participants receive 12 infusions of Aralast NP. Infusions 1 through 6 are administered at 90 mg/kg/wk and infusions 7 through 12 are administered at 180 mg/kg/wk. Part Ib consists of two groups: * Subjects aged 16 - 35 years at enrollment with new-onset T1DM * Subjects 8 - 15 years at enrollment with new-onset T1DM. Participants in Part Ib do not roll over into Part II (Refer to NCT01183455).