In August 2020 Diamyd Medical published results of their meta-analysis including data from 521 patients who participated in Phase III and Phase II trials in Europe and in the United States with the type 1 diabetes vaccine Diamyd® (GAD/alum), which was administered subcutaneously in the included studies. They reported that a subgroup of patients with the HLA DR3-DQ2 haplotype showed a dose-dependent effect of the vaccine on residual C-peptide production (i.e. beta-cell function), especially when these patients were also negative for genotypes that include the HLA DR4-DQ8 haplotype.
In September 2020 they presented the results of the Diagnode-2 phase IIb study, in which Diamyd® was administered directly into the lymph nodes of more than 80 patients. Diabeter also participated. These results confirmed the findings of the meta-analysis, that Diamyd® only works in patients with the HLA DR3-DQ2 haplotype.
Earlier this month the results of their earlier meta-analysis have been updated with the results of the Diagnode-2 study, showing in 627 patients that those with the HLA DR3-DQ2 haplotype (about half of all participants) retain about 50% more of their insulin production. Those patients who are also negative for the HLA DR4-DQ8 haplotype (about 25% of all participants) retained even more of their insulin production: about 85%.
These results underline the importance of genetics in the development of therapies for type 1 diabetes and intensified research of heterogeneity in type 1 diabetes.