The objectives of this study is to * evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes * evaluate how the above mentioned treatments influence the immune system of the subjects and interact with any viral infections * evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system, viral infections, and on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Halmstad Hospital
Halmstad, Sweden
Astrid Lindgren Children's Hospital - Huddinge
Huddinge, Sweden
Kalmar Hospital
Kalmar, Sweden
Linköping University
Linköping, Sweden
Lund University Hospital
Lund, Sweden
Skåne University Hospital, UMAS
Malmo, Sweden
Örebro University Hospital
Örebro, Sweden
Sachsska, Södersjukhuset
Stockholm, Sweden
Astrid Lindgren Children's Hospital
Stockholm, Sweden
Uddevalla Hospital
Uddevalla, Sweden
Change in C-peptide (90 minute value and AUC mean 0-120 min) during a Mixed Meal Tolerance Test from baseline to month 6, 15 and 30
Time frame: 6 months, 15 months and 30 months
Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L
Time frame: 6, 15 and 30 months
Hemoglobin A1c (HbA1c), change between baseline and subsequent visits
Time frame: 6, 15 and 30 months
Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits
Time frame: 6, 15 and 30 months
Th2-deviation of cell-mediated immune response seen, e.g. as increased ratio of IL-5, 10, 13 in comparison with IFN-gamma, TNF-alfa, IL-1 beta, IL-17, and increase of T-regulatory cells
Time frame: 6, 15 and 30 months
Decrease in inflammatory markers, e.g. TNF-alfa, IL-1 beta, IL-2, IL-17
Time frame: 6, 15 and 30 months
Fasting C-peptide, change between baseline and month 6, 15 and 30
Time frame: 6, 15 and 30 months
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