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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diamyd Therapeutics AB
• Treatments: Aluminum Hydroxide

Criteria

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