Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
NCT ID: NCT00456027
Last Updated: 2011-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2004-12-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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rhGAD65 formulated in Alhydrogel® (Diamyd®)
20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
Eligibility Criteria
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Inclusion Criteria
* Presence of GAD65 antibodies
* Detectable C-peptide level
* Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHA)
* Written informed Consent
Exclusion Criteria
* 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
30 Years
70 Years
ALL
No
Sponsors
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Diamyd Therapeutics AB
INDUSTRY
Responsible Party
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Diamyd Therapeutics AB
Principal Investigators
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Carl-David Agardh, MD, phD
Role: PRINCIPAL_INVESTIGATOR
University Hospital MAS, Malmö, Sweden
Locations
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Alingsås Hospital
Alingsås, , Sweden
Falu Hospital
Falun, , Sweden
Capio Lundby Hospital
Gothenburg, , Sweden
Härnösand Hospital
Härnösand, , Sweden
Helsingborg Hospital
Helsingborg, , Sweden
Karlstad Central Hospital
Karlstad, , Sweden
Central Hospital, Kristianstad
Kristianstad, , Sweden
Sunderby Hospital
Luleå, , Sweden
University Hospital MAS
Malmo, , Sweden
Vrinnevi Hospital
Norrköping, , Sweden
Odensala Health Clinic
Östersund, , Sweden
Skellefteå Hospital
Skellefteå, , Sweden
S:t Göran Hospital
Stockholm, , Sweden
Stockholm South General Hospital
Stockholm, , Sweden
Norrlands University Hospital
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Växjö Central Hospital
Vaxjo, , Sweden
Countries
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Other Identifiers
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EUDRACT 2004-001998-25
Identifier Type: -
Identifier Source: secondary_id
D/P2/04/2
Identifier Type: -
Identifier Source: org_study_id
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