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EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes

NCT02464033 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-03-29

Study results available
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Summary

The objectives of this study is to:

* Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept
* Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

GAD-Alum

Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)

DRUG

Vitamin D

DRUG

Etanercept

Sponsors & Collaborators

  • Swedish Child Diabetes Foundation

    collaborator OTHER

  • Ostergotland County Council, Sweden

    collaborator OTHER

  • Diamyd Medical AB

    collaborator INDUSTRY

  • Johnny Ludvigsson

    lead OTHER_GOV

Principal Investigators

  • Johnny Ludvigsson, MD,PhD,Prof · Linkoeping University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-02-25
Completion
2019-02-25

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

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 NCT02464033 on ClinicalTrials.gov