For the first time autoantigen treatment via intra-lymphatic route has been tried in T1D to preserve beta cell function. Vitamin D per os might help to gain additional efficacy.
Objectives: To evaluate the safety, and clinical and immunological response.
Patients and methods: DIAGNODE-1 is a single-center open-label pilot Phase I trial. 12 patients were enrolled, 8 /4 males/females, aged 12.6-23.1 years, T1D duration 6 months, 9 for >15 months and 4>30 months. Beta cell function was evaluated by MMTT. Immunological methods and results are presented elsewhere.
Results: The treatment was feasible, well tolerated, without any concerns regarding safety. Vitamin D concentration increased during the first 6 months from mean 60.6 (range 39.9-89.6) to 83.0 ( range 54.6-138.0). From baseline to 15 months the C-peptide AUC decreased (mean -10.4%), while fasting C-peptide increased ( mean +15%). HbA1c decreased in 8/9 patients (mean: - 24%) and insulin dose decreased in 5/9 (mean for the whole group -19%).All patients went into partial remission and IDAAC
Conclusions: A low dose GAD-alum given into lymph-nodes, together with Vitamin D per os, in recent onset T1D is feasible, tolerable, seems to be safe, and might preserve beta cell function.
Event dates:Thursday 25 October - Monday 29 October 2018
Abstract submission deadline: Monday 14 May 2018
Abstract notification: July 2018
Early registration deadline: Monday 3 September 2018
Registration deadline: Monday 15 October 2018
Contact British Society for Immunology +44 (0)20 3019 5901 congress@immunology.org
