Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies (DiAPREV-IT2)
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ClinicalTrials.gov Identifier: NCT02387164 |
Recruitment Status :
Terminated
(The study was interrupted early and terminated when only 26 out of 80 patients were enrolled due to new clinical study results indicating that the current study would not be informative.)
First Posted : March 12, 2015
Results First Posted : October 27, 2020
Last Update Posted : November 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 1 Prediabetic State | Drug: Alum-GAD Drug: Vitamin D3 | Phase 2 |
The primary objective of this study is to evaluate if immune-tolerance with Alum-formulated GAD (Diamyd), combined with high dose Vitamin D3, may delay or stop the autoimmune process leading to clinical type 1 diabetes (diagnosed according to American Diabetes Association criteria) in non-diabetic 4-17.99 year old children with ongoing beta-cell autoimmunity as indicated by positive islet autoantibodies.
The secondary objective is to demonstrate that treatment with Diamyd is safe in children at risk for type 1 diabetes.
The children will be followed for 5 years in the study. Primary endpoint is proportion of subjects diagnosed with type 1 diabetes in each treatment arm. Secondary endpoints are 1) safety, 2) change in metabolic status from normal to impaired glucose metabolism in the group of children with normal glucose metabolism at baseline screening.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official 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 |
Actual Study Start Date : | March 9, 2015 |
Actual Primary Completion Date : | October 7, 2019 |
Actual Study Completion Date : | October 7, 2019 |

Arm | Intervention/treatment |
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Experimental: Alum-GAD, Vitamin D3
Two doses à 20 microgram of subcutaneous alum-GAD (Diamyd), 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years.
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Drug: Alum-GAD
Two doses à 20 microgram 30 days apart subcutaneously administrated
Other Names:
Drug: Vitamin D3 2000 Units (IE) (50 microgram) vitamin D3 daily
Other Name: Cholecalciferol |
Placebo Comparator: Placebo, Vitamin D3
Two doses of subcutaneous placebo, 30 Days apart. Vitamin D 2000 U/Daily with start 30 days before the first injection of Diamyd. Vitamin D treatment will continue throughout the whole study period of 5 years
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Drug: Vitamin D3
2000 Units (IE) (50 microgram) vitamin D3 daily
Other Name: Cholecalciferol |
- Type 1 Diabetes Month 24 [ Time Frame: 24 months ]Number of patients diagnosed with type 1 diabetes according to ADA (American Diabetes Association) criteria in each study arm month 24
- Type 1 Diabetes Status Overall [ Time Frame: Over the entire study period up to 2 years ]Number of patients diagnosed with type 1 diabetes according to ADA (American Diabetes Association) criteria in each study arm overall. Including one patient diagnosed shortly after the month 24 visit.
- Number of Patients Developing Impaired Glucose Metabolism Until Month 18 [ Time Frame: During 18 months follow-up ]
Change in metabolic status from normal to impaired glucose metabolism during follow-up in the group of children with normal glucose metabolism at baseline screening.
Impaired glucose metabolism is defined as a) fasting plasma glucose 6.1 mmol/L or more, b) maximum plasma glucose 30, 60, 90 min during oral glucose tolerance test (OGTT) 11.1 mmol/L or more, c) 120 min plasma glucose on OGTT 7.8 mmol/L or more, d) HbA1c 39 mmol/L or more.
- Number of Patients With Progressive Impaired Glucose Metabolism Until Month 18 [ Time Frame: During 18 months follow-up ]
Number of patients who have progression from already impaired glucose metabolism from one or several criteria to additional signs of reduced glucose metabolism (within children with impaired glucose metabolism at screening).
Impaired glucose metabolism is defined as a) fasting plasma glucose 6.1 mmol/L or more, b) maximum plasma glucose 30, 60, 90 min during oral glucose tolerance test (OGTT) 11.1 mmol/L or more, c) 120 min plasma glucose on OGTT 7.8 mmol/L or more, d) HbA1c 39 mmol/L or more.
- Injection Site Reactions Day 1 [ Time Frame: Day 1 ]Number of patients experiencing injection site reactions at day 1
- Injection Site Reactions Month 1 [ Time Frame: Month 1 ]Number of patients experiencing injection site reactions at month 1
- Change From Baseline in GADA Month 1 [ Time Frame: Month 1 ]Change from baseline to month 1 in GADA (Glutamic Acid Decarboxylase Antibodies) titers
- Change From Baseline in GADA Month 12 [ Time Frame: Month 12 ]Change from baseline to month 12 in GADA titers
- Change From Baseline in GADA Month 24 [ Time Frame: Month 24 ]Change from baseline to month 24 in GADA titers

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Ongoing treatment with immunosuppressant therapy.
- Diabetes.
- Treatment with any oral or injected anti-diabetic medications
- Significantly abnormal hematology results at screening.
- Clinically significant history of acute reaction to vaccines or other drugs
- 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.
- A history of epilepsy, serious head trauma or cerebrovascular accident, or Clinical features of continuous motor unit activity in proximal muscles
- Participation in other Clinical trials with a new chemical entity within the previous 3 months.
- History of hypercalcemia.
- Unwilling to abstain from other medication with Vitamin D during the study period.
- Significant illness within 2 weeks prior to first dosing.
- Known Human Immuno Deficiency Virus infection or hepatitis.
- Presence of associated serious disease or condition.
- Diabetes-protective Human Leucocyte Antigen (HLA) DQ6.
- Females who are lactating or pregnant.
- Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last Diamyd administration.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387164
Sweden | |
Clinical Research Center, Pediatric Endocrinology, Jan Waldenströms gata 35, 60:11 | |
Malmö, Sweden, 205 02 |
Principal Investigator: | Helena Elding Larsson, MD, PhD | Lund University |
Documents provided by Helena Elding Larsson, Lund University:
Responsible Party: | Helena Elding Larsson, Docent, MD, PhD, Lund University |
ClinicalTrials.gov Identifier: | NCT02387164 |
Other Study ID Numbers: |
DiAPREV/2014 |
First Posted: | March 12, 2015 Key Record Dates |
Results First Posted: | October 27, 2020 |
Last Update Posted: | November 17, 2020 |
Last Verified: | October 2020 |
Type 1 diabetes Islet autoantibodies glutamate decarboxylase autoantibodies (GADA) Immune tolerance Prediabetes |
Glucose tolerance glutamate decarboxylase Prevention Children |
Diabetes Mellitus, Type 1 Prediabetic State Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Vitamin D |
Cholecalciferol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |