Diamyd Medical's antigen-specific immunotherapy, Diamyd® (GAD-Alum), has shown promising results in preserving beta-cell function in Type 1 Diabetes patients, according to a recent publication in the International Journal of Molecular Sciences. The DIAGNODE-B pilot trial, led by Prof. Johnny Ludvigsson, explored the safety and potential efficacy of redosing Diamyd® in individuals previously enrolled in the DIAGNODE-1 or DIAGNODE-2 trials.
DIAGNODE-B Trial Results
The trial involved six participants with the HLA DR3-DQ2 haplotype who received a fourth or fifth intralymphatic dose of Diamyd® along with vitamin D supplementation. Over a 12-month follow-up, the study found:
- Stable Insulin Production: Participants maintained endogenous insulin production, as measured by C-peptide levels.
- Improved Glycemic Control: Participants experienced stabilized HbA1c levels and increased time within the target glycemic range.
- Reduced Insulin Requirements: Participants required lower daily insulin doses.
- Sustained Immune Modulation: Immunological markers indicated a continued immune response to GAD65.
"These analyses clarify the robustness of our previous treatment results across trials in our genetically defined responder patient group, and further characterize the effect of Diamyd® on glycemic control", says Ulf Hannelius, CEO of Diamyd Medical.
Safety and Tolerability
The DIAGNODE-B trial reported no severe adverse events, reinforcing the tolerability of redosing Diamyd®. This is consistent with previous trials and supports its potential for long-term use.
Impact on Glycemic Control
Further analysis of glucose monitoring data from the DIAGNODE-2 trial, presented at the 20th Immunology of Diabetes Society (IDS) Congress, revealed that Diamyd® significantly reduces the number, duration, and amplitude of hyperglycemic excursions. This suggests a potential for improved overall glycemic control in treated patients.
Meta-Analysis and Ongoing Phase 3 Trial
An in-depth analysis of previous trials, including a meta-analysis of 627 patients, further supports the efficacy of Diamyd® in HLA DR3-DQ2 positive patients. The analysis showed a significant 48.3% improvement in C-peptide preservation (p < 0.0001) and a reduction in HbA1c of -4.8 mmol/mol (p = 0.0044) in patients treated with 3-4 injections of Diamyd® compared to placebo.
Currently, the confirmatory Phase 3 trial DIAGNODE-3 is actively recruiting patients with recent-onset Type 1 Diabetes to further evaluate the efficacy and safety of Diamyd®. An earlier readout from this trial, expected around March 2026, may support an accelerated Biologics License Application with C-peptide preservation as the primary endpoint.
