Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)

Exclusion Criteria

• •Treatment with insulin
• •Intolerance to OHA
• •Secondary diabetes mellitus
• •History of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, HIV, hepatitis)
• •Treatment with any vaccine within one 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
• •Pregnancy (or planned pregnancy within one year after 2nd administration)
• •Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
• •Significant illness other than diabetes within 2 weeks prior to first dosing
• •Unwillingness to comply with the provisions of the protocol
• •Clinically significant history of acute reaction to drugs in the past
• •Treatment with immunosuppressants