NCT05351879

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Linkoeping University · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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®

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BIOLOGICAL	GAD-alum (Diamyd) 40 μg/mL	Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) adsorbed to Alhydrogel at a concentration of 40 μg/mL and is given as a sterile solution for intralymphatic injection

Timeline

• Start date: 2022-05-09
• Primary completion: 2023-08-29
• Completion: 2023-08-29
• First posted: 2022-04-28
• Last updated: 2023-12-11

Locations

1 site across 1 country: Sweden