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

A Placebo-Controlled Study to Investigate the Impact of Diamyd® on the Diabetes Status of Patients With LADA (Latent Autoimmune Diabetes in Adult)

This is a study to investigate the safety of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart in patients with Latent Autoimmune Diabetes in Adult (LADA).

Key Inclusion Criteria:

• Male and female patients between 30-70 years of age diagnosed with type 2 diabetes within 5 years
• Presence of GAD65 antibodies
• Detectable C-peptide level
• Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHA)
• Written informed Consent

Key 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