Confirmatory Phase III Clinical Study
DIA-AID 2 (DiaPep277® - Arresting Immune Diabetes)
DIA-AID 2 is a confirmatory phase III study which is scheduled to begin during the first half of 2010. This study will be a global clinical trial which will be conducted in Europe, USA, Israel, and Latin America with approximately 450 patients being recruited at more than 100 clinical study sites.
To be eligible for the study, potential patients should be between 20 to 45 years of age and within 6 months of diagnosis of type 1 diabetes. Furthermore, the study requires a residual beta cell function when fasting of C-peptide ≥ 0.2nmol/L.
Patients will be randomized to 1.0 mg DiaPep277® or placebo with primary endpoint beta cell preservation of function.
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