Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02387164
• Date of registration: 05/03/2015
• Prospective Registration: Yes
• Primary sponsor: Lund University
• Public title: Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies DiAPREV-IT2
• Scientific title: Double-blind, Investigator-initiated Study to Determine the Effect of Alum-GAD (Diamyd) in Combination With Vitamin D3 on the Progression to Type 1 Diabetes in Children With Multiple Islet Autoantibodies
• Date of first enrolment: March 9, 2015
• Target sample size: 26
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02387164
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Sweden

Contacts

• Name: Helena Elding Larsson, MD, PhD
• Affiliation: Lund University

Key inclusion & exclusion 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.



Age minimum: 4 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Prediabetic State

Intervention(s)

Drug: Alum-GAD

Drug: Vitamin D3

Primary Outcome(s)

Type 1 Diabetes Status Overall [Time Frame: Over the entire study period up to 2 years]

Type 1 Diabetes Month 24 [Time Frame: 24 months]

Secondary Outcome(s)

Change From Baseline in GADA Month 1 [Time Frame: Month 1]

Change From Baseline in GADA Month 24 [Time Frame: Month 24]

Injection Site Reactions Month 1 [Time Frame: Month 1]

Number of Patients Developing Impaired Glucose Metabolism Until Month 18 [Time Frame: During 18 months follow-up]

Injection Site Reactions Day 1 [Time Frame: Day 1]

Number of Patients With Progressive Impaired Glucose Metabolism Until Month 18 [Time Frame: During 18 months follow-up]

Change From Baseline in GADA Month 12 [Time Frame: Month 12]

Secondary ID(s)

DiAPREV/2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Region Skane

Results

• Results available: Yes
• Date Posted: 27/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02387164