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.
Age range
12 Years – 30 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Subjects With Injection Site Reactions Month 1
Timeframe: Month 1
Number of Subjects With Injection Site Reactions Month 2
Timeframe: Month 2
Number of Subjects With Injection Site Reactions Month 3
Timeframe: Month 3
Number of Subjects With Injection Site Reactions Month 32
Timeframe: Month 32, extension period