Diabetes Prevention - Immune Tolerance

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A double-blind, randomized investigator-initiated study to determine the safety and the effect of Diamyd® on the progression to type 1 diabetes in children with multiple islet cell autoantibodies

Eligible children are 4 years or older, have positive GAD-antibodies and at least one additional autoantibody and not yet diabetes.

Objectives:

DiAPREV-IT is the first prevention study with Diamyd®, where the drug is given before onset of type 1 diabetes.

The primary objective is to demonstrate that Diamyd® is safe in children at risk for type 1 diabetes.

The secondary objective is to evaluate if Diamyd® may delay or stop the autoimmune process leading to clinical type 1 diabetes in children with ongoing persistent beta-cell autoimmunity as indicated by multiple positive islet cell autoantibodies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University
• Collaborator: Region Skane
• Treatments: Autoantibodies

Criteria

Inclusion Criteria:

1. Children from four (4) years of age and participating in DiPiS, TEDDY or Trial Net.

2. Positive GAD65Ab and at least one additional type 1 diabetes-associated autoantibody (IA-2Ab, ZnT8R/W/QAb or IAA).

3. Written informed consent from the child and the child's parents or legal acceptable representative(s) according to local regulations.

Exclusion Criteria:

1. Ongoing treatment with immunosuppressant therapy (topical or inhaled steroids are accepted).

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, other than influenza, within one month prior to the first dose of the study drug or planned treatment with vaccine up to two 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. Significant illness other than diabetes within 2 weeks prior to first dosing.

10. Known human deficiency virus (HIV) or hepatitis.

11. Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigators makes the patient non-eligible for the study.

12. Diabetes-protective HLA-DQ6-genotype.