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).
20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
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