The US Phase III study will enroll 306 new-onset type 1 diabetes patients, who are within three months of diagnosis. In one arm of the study, 102 patients will receive a 20µg injection of Diamyd on study days one and 30 to confirm earlier Phase II results. In a second arm, 102 patients will receive a 20µg injection of Diamyd on days one and 30, and then additional doses on days 90 and 270 to investigate the potential long-term beneficial effect of extra doses. In the third arm of the study, 102 patients will receive placebo.
Results of the study will be analyzed 15 months after all patients have received their first injection. A parallel similar Phase III study is planned to be conducted in Europe and together, pending a positive outcome of the trials, the studies can be used for market registration of the drug.