Safety of Diamyd® in Patients With LADA (Latent Autoimmune Diabetes in Adult)
NCT00456027 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2011-06-10
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).
Conditions
- Latent Autoimmune Diabetes in Adult (LADA)
Interventions
- DRUG
-
rhGAD65 formulated in Alhydrogel® (Diamyd®)
20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
Sponsors & Collaborators
-
Diamyd Therapeutics AB
lead INDUSTRY
Principal Investigators
-
Carl-David Agardh, MD, phD · University Hospital MAS, Malmö, Sweden
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-12-31
- Primary Completion
- 2008-03-31
- Completion
- 2008-04-30
Countries
- Sweden
Study Locations
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