Precision Prediction & Precision Medicine


Christoph Nowak, Marcus Lind, Zdenek Sumnik, et al. (including Theo Sas of Diabeter)

Intralymphatic GAD-Alum (Diamyd®) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2. J Clin Endocrinol Metab . 2022 Aug 18;107(9):2644-2651.

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

"The significant treatment effect seen on glycemic control and its correlation with the previously observed effects on the preservation of C-peptide further supports the clinical benefit of GAD-alum treatment as well as the legitimacy of the HLA DR3-DQ2 subgroup. Consequently, only persons with T1D carrying HLA DR3-DQ2 will be enrolled in the planned confirmatory phase 3 trial DIAGNODE-3 of intralymphatic GAD-alum" -

Please click here for the full-text.

Click here for more information on the Diagnode-3 study.

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