A Phase III, double-blind, placebo-controlled intervention trial to confirm the efficacy and safety of, Diamyd^® (GAD-alum) in adolescents and adults with recently diagnosed Stage 3 type 1 diabetes, carrying the genetic HLA DR3-DQ2 haplotype. The trial evaluates the effectiveness of slowing disease progression by preserving endogenous insulin producing capacity. This trial is conducted in the US, Sweden, Spain, Poland, Germany, the Czech Republic, Estonia, Hungary and the Netherlands.

• 330 participants
• 12 − 28 years
• 24 mth duration
• Type 1 Diabetes

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.

• 16 participants
• 8 − 18 years
• 12 mth duration
• Type 1 Diabetes