16 September 2026 editorial review · Trial
DIAGNODE-2: Intralymphatic GAD-alum (Diamyd) in recent-onset type 1 diabetes: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Baseline trial evidence review: A–H
Outcome: Removed prompt-history note from public narrative. Primary overall null result and prespecified genotype subgroup checked against the primary abstract; subgroup benefit is not confirmation of overall efficacy.
Registry: NCT03345004. Registered endpoint checked: Change in Stimulated C-peptide During a MMTT (Baseline and 15 months). Eligibility check: Registry age 12 Years to 24 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Intralymphatic GAD-Alum (Diamyd®) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2.; Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial.; Intralymphatic GAD-Alum (Diamyd®) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.