Diamyd Suspends US Phase 3 Trial for Its GAD65 Vaccine

In another disappointing turn, Diamyd Medical announced in late June that it was suspending a phase 3 trial for its GAD65 vaccine Diamyd. The US-based trial examined the ability of Diamyd to preserve the function of beta cells in people recently diagnosed with type 1 diabetes. While the 15-month trial was expected to complete in October, a preliminary review of the data suggested that Diamyd was ineffective at preserving the ability of beta cells to secrete insulin. Together with the lack of efficacy observed in the recently reported European phase 3 trial for the vaccine (see NewNowNext in diaTribe #33), the company decided that it was no longer justifiable to continue the study as planned. While these trials have casted doubt on the vaccine’s ability to slow the progression of type 1 diabetes in recently diagnosed people, Diamyd Medical believes the vaccine could still be effective in specific groups of people, when used in combination with other therapies, or in preventing type 1 diabetes. We certainly look forward to any future studies that may shed more light on these possible uses. Currently, a small prevention trial in children at high-risk of developing type 1 diabetes is being conducted in Sweden.  --BK