The drug Alpha-1 Antitrypsin (AAT, Aralast NP), which is being tested in this clinical trial,is an anti-inflammatory drug that affects the cells that are thought to be involved in the development of type 1 diabetes. This trial, known as RETAIN, is a two-part trial to investigate the effect of intravenous Alpha-1 Antitrypsin(AAT, Aralast NP) on preserving beta cell function and to determine if AAT will help slow the progression of type 1 diabetes.
Part I of this clinical trial is an open-label, safety and dose level study consisting of two groups. In Part I, all participants will receive the experimental drug and will be tested to see if the drug is safe and well tolerated. Two groups of participants with new-onset type 1 diabetes will be enrolled. After participants have completed the trial and a satisfactory safety review is completed, enrollment in Part II of the study will begin.
Diagnosed with type 1 diabetes within the past 100 days
Positive for at least one diabetes-related autoantibody (Anti-GAD; Anti-insulin, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody and/or ICA, or ZnT8.)
Peak stimulated C-peptide level > 0.2 pmol/mL following a mixed meal tolerance test (MMTT)
For additional information:
Lisa Meyers MSW, CDE Enrollment Coordinator 303-724-6893 Lisa.Meyers@ucdenver.edu
Dominic DiDomenico, Trial Coordinator 303-724-5687 Dominic.DiDomenico@ucdenver.edu