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Diamyd (GAD-alum) is an antigen-specific immunotherapy consisting of recombinant human glutamic acid decarboxylase 65 (GAD65) protein formulated with aluminum hydroxide (alum) as an adjuvant. It is designed to induce immune tolerance and preserve endogenous insulin production in individuals with or at risk for type 1 diabetes mellitus by modulating the autoimmune response against pancreatic beta cells. In studies led by Lund University (such as the DiAPREV-IT trials), Diamyd is evaluated in combination with high-dose vitamin D3 to enhance its immunomodulatory effects. Vitamin D3 acts as an agonist of the vitamin D receptor (VDR), which is thought to promote the induction of regulatory T cells and reduce the inflammatory environment surrounding the pancreatic islets. This combination therapy specifically targets the autoimmune process in patients carrying the HLA DR3-DQ2 haplotype and has received FDA Fast Track and Orphan Drug designations.
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