A recent publication in the International Journal of Molecular Sciences highlights the potential benefits of redosing Diamyd® (GAD-Alum) in individuals with Type 1 Diabetes. The article details findings from the investigator-initiated DIAGNODE-B pilot trial, which assessed the safety and efficacy of administering additional doses of Diamyd®, an antigen-specific immunotherapy, to preserve beta-cell function. The study suggests that redosing may offer a viable strategy for maintaining insulin production and improving glycemic control in this patient population.
The DIAGNODE-B trial, conducted in Linköping, Sweden, 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® along with vitamin D supplementation. Over a 12-month follow-up period, the study evaluated various clinical and immunological parameters to determine the impact of redosing.
Clinical and Immunological Outcomes
The results indicated that participants experienced stabilized endogenous insulin production, as measured by C-peptide levels. Furthermore, improvements in glycemic control were observed, along with a reduction in daily insulin requirements. Specifically, participants showed stable HbA1c levels and increased time within the target glycemic range. Immunological assessments revealed increased GAD65-induced cytokine responses and antibody titers, consistent with findings from prior trials, suggesting sustained immune modulation.
Safety Profile
Importantly, the trial reported no severe adverse events, reinforcing the tolerability of redosing Diamyd®. This finding is crucial for establishing the safety of repeated administrations of the immunotherapy in individuals with Type 1 Diabetes.
Diamyd Medical's Perspective
Diamyd Medical is developing precision medicine therapies for Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® has received Orphan Drug Designation in the U.S., as well as Breakthrough and Fast Track Designations from the FDA for Stage 3 Type 1 Diabetes. It also has Fast Track Designation for Stages 1 and 2. The confirmatory Phase III trial DIAGNODE-3 is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes across multiple sites in Europe and the U.S.
