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

NCT04262479 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-06-08

Study results available
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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.

Conditions

  • Latent Autoimmune Diabetes in Adults

Interventions

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

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Diamyd Medical AB

    collaborator INDUSTRY

  • Karolinska Institutet

    collaborator OTHER

  • Linkoeping University

    collaborator OTHER_GOV

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Anne Hildur Henriksen, MD PhD · St Olavs Hospital, Medisinsk Klinikk

  • Torstein Baade Rø, MD · Norwegian University of Science and Technology, IKOM

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2022-05-05
Completion
2022-05-05

Countries

  • Norway
  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262479 on ClinicalTrials.gov