DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring 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
Eligibility 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
Sites / Locations
- Halmstad Hospital
- Astrid Lindgren Children's Hospital - Huddinge
- Kalmar Hospital
- Linköping University
- Lund University Hospital
- Skåne University Hospital, UMAS
- Sachsska, Södersjukhuset
- Astrid Lindgren Children's Hospital
- Uddevalla Hospital
- Örebro University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
GAD-Alum (Diamyd) 20µg, Vitamin D and Ibuprofen
GAD-Alum (Diamyd) 20µg and Vitamin D
GAD-Alum (Diamyd) 20 µg x 2 and Vitamin D
Placebo
GAD-Alum (Diamyd) 20 µg given twice with one month interval Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450 Ibuprofen, 400 mg/day, from Day 1 to Day 90
GAD-Alum (Diamyd) 20 µg given twice with one month interval Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450
GAD-Alum (Diamyd) 20 µg X 2 given twice with one month interval Vitamin D oral drops, 2000 IU/day, from Day 1 to Day 450