GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: GAD-Alum; Vitamin D
Intervention MeSH terms: Vitamin D
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 12 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Diamyd; Diabetes; Juvenile Diabetes; Diabetes Type 1; Type 1 Diabetes; Autoimmune Diabetes; Insulin Dependent Diabetes; Type 1 Diabetes Mellitus; rhGAD65 (Recombinant Human GAD with molecular mass 65,000); GAD65; GAD-Alum; Diabetes Mellitus; Diabetes mellitus Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Vitamin D

Summary:

      The objectives of the main study is to:

        -  Evaluate the safety of giving GAD-Alum (Glutamic acid decarboxylase) (Diamyd) directly
           into lymph glands in combination with an oral vitamin D regimen

        -  Evaluate how the above mentioned treatments influence the immune system and endogenous
           insulin secretion.

      The objective of the sub-study is to:

        -  Evaluate safety after a fourth injection with 4 μg GAD-Alum direct into an inguinal
           lymph gland in 3 adult patients from the main study

        -  Evaluate how the above mentioned treatment influences the immune system and endogenous
           insulin secretion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Informed consent given by patients

          2. Type 1 diabetes according to the ADA (American Diabetes Association) classification
             with < 6 months diabetes duration

          3. Age 12.00-29.99 years at diagnosis of Type 1 diabetes

          4. Fasting C-peptide ≥0.12 nmol/L

          5. Pos GADA(Antibodies to GAD with molecular mass 65,000) but < 50 000 random units

          6. Females must agree to avoid pregnancy and have a negative urine pregnancy test

          7. Patients of childbearing potential must agree to using adequate contraception, until 1
             year after the last administration of GAD-Alum.

        Exclusion Criteria:

          1. Previous or current treatment with immunosuppressant therapy (although topical or
             inhaled steroids are accepted)

          2. Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of
             headache or in connection with fever a few days will be accepted)

          3. Treatment with any oral or injected anti-diabetic medications other than insulin

          4. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such
             medication during the trial

          5. A history of anaemia or significantly abnormal haematology results at screening

          6. A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features
             of continuous motor unit activity in proximal muscles

          7. Clinically significant history of acute reaction to vaccines or other drugs in the
             past

          8. Treatment with any vaccine, including influenza vaccine, within 4 months prior to
             planned first study drug dose or planned treatment with any vaccine up to 4 months
             after the last injection with study drug.

          9. Participation in other clinical trials with a new chemical entity within the previous
             3 months

         10. Inability or unwillingness to comply with the provisions of this protocol

         11. A history of alcohol or drug abuse

         12. A significant illness other than diabetes within 2 weeks prior to first dosing

         13. Known human immunodeficiency virus (HIV) or hepatitis

         14. Females who are lactating or pregnant (the possibility of pregnancy must be excluded
             by urine βHCG (beta-human chorionic gonadotropin) on-site within 24 hours prior to the
             GAD-Alum treatment)

         15. Males or females not willing to use adequate contraception until 1 year after the last
             GAD-Alum treatment

         16. Presence of associated serious disease or condition, including active skin infections
             that preclude subcutaneous injection, which in the opinion of the investigator makes
             the patient non-eligible for the study

         17. Deemed by the investigator not being able to follow instructions and/or follow the
             study protocol