CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04262479
NCT04262479Phase 2Completed
CompareCT.gov

A Pilot Study on Safety, Feasibility and Insulin-promotion by Intra-inguinal Lymph Node Injections of Glutamic Acid Decarboxylase (GAD) in Patients With LADA Type of Diabetes

Norwegian University of Science and Technology·interventional·Posted Feb 10, 2020·Updated Jun 8, 2025

In Brief

A Phase 2 clinical trial evaluating recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel and Vitamin D for Latent Autoimmune Diabetes in Adults. Completed, enrolled 14 participants across 2 sites in 2 countries.

Detailed Summary

This study will evaluate the effects of 3 intra-nodal injections of GAD-alum (Diamyd), together with oral vitamin D supplementation. Safety and feasibility of the treatment will be evaluated and also effects on the immune system and on the preservation of endogenous insulin production.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLatent Autoimmune Diabetes in Adults
CountriesNorway, Sweden
CollaboratorsSt. Olavs Hospital, Diamyd Medical AB, Karolinska Institutet, Linkoeping University

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 10, 2020
Enrollment StartMar 2, 2020
Primary CompletionMay 5, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.4 years ago

Interventions

recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogeldrug

3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden

Vitamin Ddrug

1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden