Phase 3 Study of Diamyd for Type 1 Diabetes

Diamyd Medical's European Phase 3 study of Diamyd for the treatment of newly diagnosed type 1 diabetes patients 10–20 years old did not reach its primary endpoint of preserving beta cell function at 15 months or follow-up compared to placebo. The multinational, multicenter, double-blind, randomized, placebo-controlled trial enrolled more than 320 patients between 10 and 20 years of age who were diagnosed with type 1 diabetes within three months of entering the study. The study includes three treatment arms in which one-third of the patients received four subcutaneous injections of Diamyd (Days 1, 30, 90 and 270); one-third received two injections of Diamyd (Days 1 and 30); and one-third received placebo. The primary efficacy variable of the study was meal-stimulated C-peptide as a measure of beta cell function.

Diamyd's active substance is a human protein GAD65 (Glutamic acid decarboxylase isoform 65 kDa) and is an antigen-based diabetes therapy under development.

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