Status:
COMPLETED
Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
Lead Sponsor:
Diamyd Therapeutics AB
Conditions:
Latent Autoimmune Diabetes in Adult (LADA)
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief 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).
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00456027
Start Date
December 1 2004
End Date
April 1 2008
Last Update
June 10 2011
Active Locations (17)
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1
Alingsås Hospital
Alingsås, Sweden
2
Falu Hospital
Falun, Sweden
3
Capio Lundby Hospital
Gothenburg, Sweden
4
Härnösand Hospital
Härnösand, Sweden