A 1‐year pilot study of intralymphatic injections of GAD‐alum in individuals with latent autoimmune diabetes in adults (LADA) with signs of high immunity: No safety concerns and resemblance to juvenile type 1 diabetes
Authors' conclusion
Intralymphatic treatment with GAD-alum in LADA is without clinical or other safety concerns over a 12-month period. As in a similar protocol used in type 1 diabetes, treatment exerts a strong immunological impact and is compatible with protection of beta-cell function preferentially in HLA-DR3DQ2 LADA patients. These findings pave the way for a randomized controlled trial in this important subgroup of LADA patients.
Study context
- Population
- People with newly diagnosed LADA (age 30–62 years) with high glutamic acid decarboxylase (GADA) levelsall completed
- Participants
- 14 people
- Outcome
- Safety (adverse effects, laboratory variables)
- Follow-up
- 12 months
Methodological detailssingle-group, open-label
- Single-group
- Open-label
Main finding
As reported in the abstract
Safety
- Clinical adverse effects were minor and transient; measured laboratory variables were unaffected
- All participants completed the study
Further findings
| Outcome | P value |
|---|---|
| Beta-cell function (C-peptide glucagon tests) by HLA DR3DQ2 carriageHLA DR3DQ2 carriers vs Non-carriers | P < 0.05 |
- Beta-cell function (C-peptide glucagon tests) by human leukocyte antigen (HLA) DR3DQ2 carriage: beta-cell function appeared stable preferentially in carriers
- Beta-cell function (C-peptide glucagon tests) by HLA DR3DQ2 carriage: 7 carriers vs 7 non-carriers
Immunological response
- Treatment raised GADA levels, elicited strong effects on PBMC reactivity to GAD and raised cytokine/chemokine levels
Safety
Adverse effects · 12 months
- Clinical adverse effects were minor and transient; laboratory variables unaffected
Original publication
A 1‐year pilot study of intralymphatic injections of GAD‐alum in individuals with latent autoimmune diabetes in adults (LADA) with signs of high immunity: No safety concerns and resemblance to juvenile type 1 diabetes. Diabetes Obes Metab. Published 14 August 2023. doi:10.
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