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

Diamyd Therapeutics

Status and phase

Completed

Phase 2

Conditions

Latent Autoimmune Diabetes in Adult (LADA)

Treatments

Drug: rhGAD65 formulated in Alhydrogel® (Diamyd®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00456027

D/P2/04/2

EUDRACT 2004-001998-25

Details and patient eligibility

About

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).

Enrollment

160 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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