NCT04262479

Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of the trial is to evaluate the effects of 3 intra-nodal injections of GAD-alum, together with oral vitamin D supplementation, in a population of LADA patients with high GADA titers. Effects will be summarized at 5 and 12 months after the first injection. * The primary objective is to evaluate safety and feasibility of this treatment regimen. * Secondary objectives are to test if the treatment induces a strong GAD-specific immune response similar to what has previously been observed in type 1 diabetes patients and to test for indications of preservation of endogenous insulin production. The study is an open label Phase IIa feasibility trial. It is a pilot study that does not include a placebo arm. Antidiabetic medication in the form of metformin is acceptable before and during the trial. Study participants must be insulin independent at baseline, but if the need for insulin treatment develops during the trial, such treatment will be given. GAD-alum will be injected directly into an inguinal lymph node by a qualified radiologist. Patients will be followed for a total of 12 months during which their endogenous insulin production and immune response will be evaluated at regular intervals throughout the study period. Urine and blood samples will be taken for safety, diabetes status assessments, vitamin D levels and immunological assessments. Concomitant medication and demographics will be collected.

Conditions

• Latent Autoimmune Diabetes in Adults

Interventions

Type	Name	Description
DRUG	recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel	3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden
DRUG	Vitamin D	1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden

Timeline

• Start date: 2020-03-02
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2020-02-10
• Last updated: 2025-06-08
• Results posted: 2025-06-08

Locations

2 sites across 2 countries: Norway, Sweden