Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies
Condition: Diabetes Mellitus, Type 1; Prediabetic State
MeSH terms: Diabetes Mellitus, Type 1; Prediabetic State
Intervention: Alum-GAD; Vitamin D3
Intervention description: Two doses à 20 microgram 30 days apart subcutaneously administrated; 2000 Units (IE) (50 microgram) vitamin D3 daily
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 4 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Type 1 diabetes; Islet autoantibodies; glutamate decarboxylase autoantibodies (GADA); Immune tolerance; Prediabetes; Glucose tolerance; glutamate decarboxylase; Prevention; Children

Summary:

      The purpose of this study is to evaluate if immune-tolerance with Alum-formulated GAD
      (Diamyd), in combination with high dose Vitamin D3, may delay or stop the autoimmune process
      leading to clinical type 1 diabetes in non-diabetic children with ongoing beta-cell
      autoimmunity as indicated by positive islet autoantibodies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 4-17.99 years of age with positive autoantibodies to glutamate decarboxylase
             (GADA) and at least one additional type 1 diabetes associated autoantibody (to
             insulinoma associated protein 2 (IA-2A), Zinktransporter 8 (ZnT8R/Q/WA) or insulin
             (IAA)).

          -  Written informed consent from the child and the childs legal representative(s).

        Exclusion Criteria:

          1. Ongoing treatment with immunosuppressant therapy.

          2. Diabetes.

          3. Treatment with any oral or injected anti-diabetic medications

          4. Significantly abnormal hematology results at screening.

          5. Clinically significant history of acute reaction to vaccines or other drugs

          6. Treatment with any vaccine within one month prior to the first dose of the study drug
             or planned treatment with vaccine up to three months after the last injection with the
             study drug.

          7. A history of epilepsy, serious head trauma or cerebrovascular accident, or Clinical
             features of continuous motor unit activity in proximal muscles

          8. Participation in other Clinical trials with a new chemical entity within the previous
             3 months.

          9. History of hypercalcemia.

         10. Unwilling to abstain from other medication with Vitamin D during the study period.

         11. Significant illness within 2 weeks prior to first dosing.

         12. Known Human Immuno Deficiency Virus infection or hepatitis.

         13. Presence of associated serious disease or condition.

         14. Diabetes-protective Human Leucocyte Antigen (HLA) DQ6.

         15. Females who are lactating or pregnant.

         16. Males or females not willing to use adequate contraception, if sexually active, until
             1 year after the last Diamyd administration.