TrialNet 08: Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-alum) on the Progression of Type 1 Diabetes in New Onset Subjects

This multicenter, double-masked, randomized, controlled trial evaluated whether treatment of with a target antigen (glutamic acid decarboxylase) could modulate aggressive autoimmunity effects in subjects recently diagnosed with type 1 diabetes mellitus. Subjects were randomized via a 1:1:1 ratio into one of three treatment groups: three injections of 20 μg GAD-alum, two injections of GAD-alum and one of aluminum hydroxide alone (placebo), or three injections of aluminum hydroxide. These subcutaneous injections were completed at baseline, four weeks, and twelve weeks. All subjects received intensive diabetes management with the goal of achieving excellent glycemic control. Stimulated C-peptide levels were measured at the year 1 visit via a mixed meal tolerance test (MMTT). Subjects continued follow up for a second year including the performance of a MMTT every 6 months.