Diabetes Mellitus, Type 1
Conditions
Keywords
Diamyd, Diabetes, Juvenile Diabetes, Diabetes type 1, Autoimmune Diabetes, Insulin dependent Diabetes, Type 1 diabetes, Type 1 diabetes mellitus, rhGAD65, GAD, GAD65, GAD-alum, Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Vitamin D, Ibuprofen
Brief summary
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
Interventions
DRUGIbuprofen
BIOLOGICALGAD-Alum (Diamyd) 20 µg
BIOLOGICALGAD-Alum (Diamyd) 20 µg X 2
DRUGVitamin D
Sponsors
Swedish Child Diabetes Foundation
The Research Council of South East Sweden (FORSS)
Diamyd Medical AB
Johnny Ludvigsson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Male and female patients between 10 and 18 years of age * Insulin dependent Type 1 Diabetes mellitus diagnosed within the previous 4 months at time of screening * Fasting C-peptide level at time of screening above or equal to 0.12 nmol/L * Elevated GAD65 antibodies (GADA) at time of screening Main
Exclusion criteria
* Treatment with immunosuppressants, continuous anti-inflammatory drug, Vitamin D or any anti-diabetic medications other than insulin * A history of certain diseases or conditions (e.g. anemia, HIV, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc) * Treatment with any vaccine within 4 months prior to first planned administration of GAD-Alum/placebo or planned treatment with vaccine up to 4 months after the last injections with GAD-Alum/Placebo, including influenza vaccines * Participation in other clinical trials with a new chemical entity within the previous 3 months * Pregnancy or planned pregnancy within 1 year after the last GAD-Alum/placebo dose * Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 6 months, 15 months and 30 months |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (HbA1c), change between baseline and subsequent visits | 6, 15 and 30 months |
| Exogenous insulin dose per kg body weight and 24 hours, change between baseline and subsequent visits | 6, 15 and 30 months |
| Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L | 6, 15 and 30 months |
| Decrease in inflammatory markers, e.g. TNF-alfa, IL-1 beta, IL-2, IL-17 | 6, 15 and 30 months |
| Fasting C-peptide, change between baseline and month 6, 15 and 30 | 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 | 6, 15 and 30 months |
Countries
Sweden
Outcome results
None listed