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-1 and DIAGNODE-2, as well as the large-scale meta-analysis encompassing data from more than 600 individuals from previous Phase II and Phase III trials using Diamyd