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 .
An open-label investigator-initiated clinical trial where Diamyd® (GAD-alum) is given directly into the lymph node in type 1 diabetes patients carrying the genetically defined haplotype HLA DR3-DQ2 and previously treated with intralymphatic injections of Diamyd® in the DIAGNODE-1 or DIAGNODE-2 trial. The aim of the trial is to evaluate the safety of a booster (fourth/fifth) injection with Diamyd® and the effect on the immune system and the endogenous insulin production.