Update on the design of a Phase III Precision Medicine trial with the Diabetes Vaccine Diamyd®

The  upcoming Phase III trial with Diamyd[®] in new-onset type 1 diabetes will be based on the first precision medicine approach in the field. The trial is designed to confirm the effect and safety of Diamyd[®] in individuals recently diagnosed with type 1 diabetes who carry the genetic HLA DR3-DQ2 haplotype.The Phase III trial is designed to enroll approximately 330 individuals aged 12 to 28, recently diagnosed with type 1 diabetes, who carry the HLA DR3-DQ2 haplotype. This patient population is based on clinical efficacy and safety results from the Phase IIa and Phase IIb trials DIAGNODE-