Earlier we reported publication of the first results of the Diagnode-1 and Diagnode-2 studies, showing that intralymphatic injection of diabetes vaccine GAD-alum (Diamyd®) combined with vitamin supplementation is a safe treatment, resulting in a slower decrease in C-peptide (i.e. insulin) production for people with type 1 diabetes carrying the HLA DR3-DQ2 haplotype.

The aim of the analysis of Diagnode-2 study reported here was to assess the efficacy of intralymphatic GAD-alum treatment on glycemic control as measured by CGM-recorded blood glucose values, focusing on participants with the HLA DR3-DQ2 haplotype.

Key findings:

• Participants with the HLA DR3-DQ haplotype subgroup treated with GAD-alum showed a higher percentage time in range (TIR), compared with the placebo group
• Participants with the HLA DR3-DQ haplotype subgroup also showed a significantly slower decrease of TIR over time (15 months), compared with the placebo group
• In terms of glycemic variability GAD-alum treatment resulted in lower standard deviation (SD), but not in changes in coefficient of variation (CV) of blood glucose values
• Participants with the HLA DR3-DQ haplotype showed lower glucose management (GMI: “estimated HbA1c”) than participants without this haplotype
• Regardless of haplotype and at all three time points (baseline, 6 months, 15 months) there were associations between remaining C-peptide production (up to 600 pmol/L) and:
  • TIR (positive association)
  • percentage of time above range (TAR: > 13.9 mmol/L)

Based on these results the authors also state

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