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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
20 micrograms of rhGAD65 formulated in Alhydrogel® administered subcutaneously twice 4 weeks apart
Alingsås Hospital
Alingsås, Sweden
Falu Hospital
Falun, Sweden
Capio Lundby Hospital
Gothenburg, Sweden
The development over time of safety variables, i.e. injection site discomfort, vital signs, laboratory values and AEs/SAEs as well as development of diabetes status, i.e. HbA1c, C-peptide, blood glucose and insulin requirement.
Time frame: 30 months
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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
...and 7 more locations