Evaluation of a Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes
brief summary
The objective of the study is to evaluate the feasibility and safety of administering a 4th or 5th intralymphatic booster dose of GAD-alum (Diamyd®) to T1D patients carrying HLA DR3-DQ2, who have earlier been treated with three or four intralymphatic doses of GAD-alum (Diamyd®) respectively.
detailed description
The study is a phase I/II, single arm, open label pilot clinical trial. Eligible patients will receive one booster injection of Diamyd® administered into an inguinal lymph node.
The patients will be assessed for eligibility at the screening visit (Visit 1). Patients with a Vitamin D level \<100 nmol/L (40 ng/mL) at screening will receive oral Vitamin D supplementation (2000 IU daily) for 60 days, starting 30 days prior to the injection. On Visit 2 (Day 0), patients eligible for the study will receive one intralymphatic injection of 4µg Diamyd®
official title
A Phase I/II Open Label Pilot Study to Evaluate the Safety and Feasibility of an Additional Intralymphatic Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes