The efficacy of intralymphatic administration of Diamyd® is being confirmed in the first ever precision medicine Phase III trial DIAGNODE-3. A booster regimen is being evaluated in the Phase II trial DIAGNODE-B.
A Phase III, double-blind, placebo-controlled intervention trial, where Diamyd® (GAD-alum) is administered directly into lymph nodes in adolescents and adults with recently diagnosed Type 1 Diabetes, carrying the genetic HLA DR3-DQ2 haplotype. The trial evaluates the effectiveness of preserving the insulin producing capacity. This trial is conducted in six countries: Sweden, Spain, Poland, Germany, the Czech Republic and the Netherlands .
A Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® in individuals at risk for Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.The main goal is to study the feasibility and safety of administering two or three intralymphatic injections of Diamyd® to individuals at-risk for T1D (stage 1 or stage 2), carrying HLA DR3-DQ2. The study will also evaluate the effect of Diamyd treatment on the individuals’ immune system and metabolic status as well as progression from Stage 1 to Stage 2 or Stage 3 T1D.DiaPrecise is the first precision prevention trial with Diamyd®, and is conducted under the ASSET program (www.asset.healthcare) funded by the Swedish Innovation Agency VINNOVA.