A recent publication in the International Journal of Molecular Sciences highlights the potential benefits of redosing Diamyd® (GAD-Alum) in patients with Type 1 Diabetes. The investigator-initiated DIAGNODE-B pilot trial, led by Prof. Johnny Ludvigsson in Linköping, Sweden, explored the safety and efficacy of administering repeat doses of the antigen-specific immunotherapy.
The DIAGNODE-B trial included six participants with the HLA DR3-DQ2 haplotype who had previously participated in the DIAGNODE-1 or DIAGNODE-2 trials. These individuals received a fourth or fifth intralymphatic dose of Diamyd® in conjunction with vitamin D supplementation. The study followed participants for 12 months, monitoring various clinical and immunological parameters.
Clinical and Immunological Outcomes
The results indicated that redosing with Diamyd® was safe and well-tolerated, with no severe adverse events reported. Clinically, participants exhibited stabilized endogenous insulin production, as measured by C-peptide levels. Furthermore, they experienced improved glycemic control, reflected in stable HbA1c levels and increased time within the target glycemic range. Notably, the participants also required reduced daily insulin doses.
From an immunological perspective, the study observed increased GAD65-induced cytokine responses and antibody titers, consistent with findings from previous trials. These immunological changes suggest that redosing Diamyd® can sustain immune modulation in patients with Type 1 Diabetes.
Implications for Type 1 Diabetes Treatment
Type 1 Diabetes is an autoimmune disease characterized by the destruction of insulin-producing beta cells in the pancreas. Current treatments primarily focus on managing blood glucose levels through insulin therapy. Diamyd® aims to address the underlying autoimmune process by modulating the immune system to preserve beta-cell function.
The DIAGNODE-B trial provides preliminary evidence that redosing Diamyd® may offer sustained clinical benefits in a subset of patients with Type 1 Diabetes. While the sample size was small, the observed improvements in insulin production, glycemic control, and insulin requirements warrant further investigation in larger, controlled studies.
Diamyd Medical is currently conducting the DIAGNODE-3, a confirmatory Phase III trial, actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US.
