Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes

Key Inclusion Criteria: * Male and female patients between 10 and 18 years of age, diagnosed with type 1 diabetes within 18 months * Fasting C-peptide level above 0.1 nmol/l * Presence of GAD65 antibodies * Written informed consent (patient and parent/guardian) Key Exclusion Criteria: * Secondary diabetes mellitus or MODY * Treatment with immunosuppressants * Treatment with any vaccine within 1 month prior to first Diamyd® dose or planned treatment with vaccine up to 2 months after the second Diamyd® dose * Participation in other clinical trials with a new chemical entity within the previous 3 months * History of certain diseases or conditions (e.g. epilepsy, anaemia, alcohole or drug abuse) * HIV or hepatitis * Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study * Pregnancy (or planned pregnancy within one year after 2nd administration)