The randomized, placebo-controlled study was led by Professor Helena Elding Larsson at Lund University and Skåne University Hospital in Malmö. The results will be published in the journal Diabetologia. The trial included 50 children aged 4–17 who were at increased risk of developing type 1 diabetes (stage 1 or stage 2) but did not yet need daily insulin injections. Participants were followed for a median of 12.9 years.

In children with the HLA DR3-DQ2 genotype, retogatein significantly extended the time to stage 3 disease (p=0.018). The estimated median was 9.0 years, compared with 3.4 years for placebo.

“These results support retogatein as a potentially disease-modifying treatment for children with GAD antibodies and at least one additional islet autoantibody, who also belong to a genetically defined responder group,” says Helena Elding Larsson.

“These long-term results, together with retogatein’s well-documented safety profile in more than 1,000 patients, the simplicity of the treatment, and its specific induction of tolerance to the autoantigen rather than immunosuppression, provide strong reasons to confirm the effect of retogatein in children with GAD antibodies and a relevant genetic profile. The results show the potential to give children in need of treatment several extra years without external insulin, and potentially a longer life,” says Anders Essen-Möller, CEO of Diamyd Medical.