A Phase 3, 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 the US, Sweden, Spain, Poland, Germany, the Czech Republic and the Netherlands .

• 330 participants
• 12 − 29 years
• 24 mth duration
• Type 1 Diabetes

A Phase 2 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 Type 1 Diabetes (Stage 1 or Stage 2), carrying HLA DR3-DQ2 haplotype. The study will also evaluate the effect of Diamyd(R) treatment on the individuals’ immune system and metabolic status as well as progression from Stage 1 to Stage 2 or Stage 3 Type 1 Diabetes.

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