A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT

Main Inclusion Criteria: * Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening * Fasting C-peptide level at time of screening above 0.1 nmol/L * Elevated GAD65 antibodies (GADA) at time of screening * Male and female patients between 10 and 20 years of age Main Exclusion Criteria: * Treatment with immunosuppressants or any anti-diabetic medications other than insulin * A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc) * Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine * Participation in other clinical trials with a new chemical entity within the previous 3 months * Pregnancy or planned pregnancy within 1 year after the last Diamyd dose * Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study