A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) \[Glassia®\] in the Treatment of New Onset Type-1 Diabetes. The study objectives are: * To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes * To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes pediatric and young adult population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Placebo
Soroka Medical Center
Beersheba, Israel
Rambam Medical Center
Haifa, Israel
Schneider Children's Medical Center
Pethach Tikva, Israel
Assaf Harofe Medical Center
Ẕerifin, Israel
Beta cell function
Beta cell function (measured by C peptide)
Time frame: 12 months from baseline
Glycemic control
Glycemic control expressed in HbA1c level
Time frame: 12 months from baseline
Beta cell function
Time frame: 12 months from baseline
Insulin dose
Time frame: 12 months from baseline
Hypoglycemic episodes
Time frame: 12 months from baseline
Safety parameters
Adverse events, vital signs, physical examination
Time frame: 12 months from baseline
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