GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes … (NCT02352974) | Clinical Trial Compass
CompletedPhase 1
GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1)
Sweden12 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range12 Years – 30 Years
SexALL
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Inclusion criteria
✓. Informed consent given by patients
✓. Type 1 diabetes according to the ADA (American Diabetes Association) classification with \< 6 months diabetes duration
✓. Age 12.00-29.99 years at diagnosis of Type 1 diabetes
✓. Fasting C-peptide ≥0.12 nmol/L
✓. Pos GADA(Antibodies to GAD with molecular mass 65,000) but \< 50 000 random units
✓. Females must agree to avoid pregnancy and have a negative urine pregnancy test
✓. Patients of childbearing potential must agree to using adequate contraception, until 1 year after the last administration of GAD-Alum.
Exclusion criteria
✕. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
✕. Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
What they're measuring
1
Number of Subjects With Injection Site Reactions Month 1
Timeframe: Month 1
2
Number of Subjects With Injection Site Reactions Month 2
Timeframe: Month 2
3
Number of Subjects With Injection Site Reactions Month 3
Timeframe: Month 3
4
Number of Subjects With Injection Site Reactions Month 32
✕. Treatment with any oral or injected anti-diabetic medications other than insulin
✕. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial
✕. A history of anaemia or significantly abnormal haematology results at screening
✕. A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles
✕. Clinically significant history of acute reaction to vaccines or other drugs in the past
✕. 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.