Diamyd Medical is currently initiating a Phase II clinical trial at the Clinical Research Centre at Lund University evaluating intralymphatic administration of Diamyd in healthy children at risk for type 1 diabetes carrying the HLA DR3-DQ2 type 1 diabetes. DiAPREV-IT (EudraCT 2008-007484-16) evaluated the effect of two subcutaneous injections of Diamyd on preventing the progression to Stage 3 type 1 diabetes diagnosis in 50 children aged 4-<18 years positive for GADA and classified as Stage 1 or Stage 2 type 1 diabetes over a 5 year trial period compared to placebo. Results were presented in 2017 in Pediatric Diabetes.

The results showed that GAD-Alum as a subcutaneous prime and boost injection was safe in prediabetic young children. but did not affect progression to type 1 diabetes. The trial was later shortened to follow 26 children for two years.

In September 2020 the meta-analysis of the combined data from DiAPREV-IT and DiAPREV-IT2 showed that treatment with two subcutaneous injections ofDiamyd, while not reaching statistical significance, might have a positive effect on the progression to type 1 diabetes in individuals positive for HLA DR3-D Second Quarter while no benefit compared to placebo was seen in individuals negative for HLA DR3- Diamyd trials in recent onset type 1 diabetes.