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Evaluation of a Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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® ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05351879
Study type Interventional
Source Linkoeping University
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 9, 2022
Completion date August 29, 2023
View Details
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