Delayed time to stage 3 type 1 diabetes after GAD-alum treatment in HLA-DR3-DQ2-positive children: follow-up of the randomised placebo-controlled Diabetes Prevention – Immune Tolerance trial
Authors' conclusion
In the current study, GAD-alum significantly delayed progression to stage 3 type 1 diabetes in HLA-DR3-DQ2-positive children with multiple islet autoantibodies, while the opposite was observed in the subgroup without this haplotype
Study context
- Population
- Children 4–17.99 years old with GADA and at least one additional islet autoantibody; subgroups with and without HLA-DR3-DQ2 haplotype49 analysed
- Participants
- 50 children
- Comparison
- GAD-alum vs placebo
- GAD-alumn = 25
- Placebon = 25reference
- Primary endpoint
- Time from treatment start to stage 3 T1D diagnosis
- Follow-up
- Median 12.9 years (range 1.0-13.8 years)
Methodological detailsinvestigator-initiated, placebo-controlled, masked, stratified by islet autoantibody status, Original RCT did not reach significant treatment effect in predefined analyses, Outcome data from Swedish National Diabetes Registry or telephone interviews
- Investigator-initiated
- Placebo-controlled
- Masked
- Stratified by islet autoantibody status
- Original RCT did not reach significant treatment effect in predefined analyses
- Outcome data from Swedish National Diabetes Registry or telephone interviews
Primary result
As reported in the abstract
Time to stage 3 T1D · median 12.9 years follow-up
GAD-alum vs PlaceboHazard ratio (95% CI)P value
Overall population, n=49
1.017(0.523–1.977)
P = 0.960HLA-DR3-DQ2-positive, n=27
0.315(0.120–0.823)
P = 0.018HLA-DR3-DQ2-negative, n=22
3.500(1.052–11.630)
P = 0.040- Progressed to stage 3 T1D, overall
- 35 of 49
- Progressed to stage 3 T1D, HLA-DR3-DQ2-positive
- 22 of 27
Further findings
Median time to stage 3 T1D (Kaplan-Meier), HLA-DR3-DQ2-positive
P = 0.096
| Outcome | IRR (95% CI) | P value | |
|---|---|---|---|
| Incidence rate of stage 3 T1D, HLA-DR3-DQ2-positiven=27 | 0.419 (0.176–0.997) | P = 0.049 | |
| 0.10.31310Incidence rate ratio (log scale) |
Original publication
Delayed time to stage 3 type 1 diabetes after GAD-alum treatment in HLA-DR3-DQ2-positive children: follow-up of the randomised placebo-controlled Diabetes Prevention – Immune Tolerance trial. Diabetologia. Published 28 September 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →