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Diabetes Virus Detection Project, Intervention With GAD-alum

NCT01129232 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-05-17

No results posted yet for this study

Summary

The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).

Conditions

  • Diabetes, Type I
  • Enterovirus Infections
  • Autoimmunity

Interventions

DRUG

GAD-alum

20 µg of GAD-alum injected sc after the biopsy, and repeated after one month

OTHER

Placebo

Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Knut Dahl-Jorgensen, Prof · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Norway

Study Locations

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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 NCT01129232 on ClinicalTrials.gov