The study will comprise 306 new onset type 1 diabetes patients. Diamyd Medical is planning to file clinical trial applications in another three to four European countries and include additionally 20 clinics in the study.
Elisabeth Lindner, president and CEO of Diamyd Medical, said: “The approval from the Swedish agency is another important step in the development of Diamyd towards the market. Last week we received authorization from the FDA to start a parallel Phase III trial in the US, and together with TrialNet’s planned study in the US, the interest in Diamyd is strong.”