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DIABGAD - Trial to Preserve Insulin Secretion in Type 1 Diabetes Using GAD-Alum (Diamyd) in Combination With Vitamin D and Ibuprofen

NCT01785108 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-08-23

No results posted yet for this study

Summary

The objectives of this study is to

* evaluate the safety and influence of treatment with GAD-Alum (Diamyd) combined with Vitamin D and Ibuprofen on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes
* evaluate how the above mentioned treatments influence the immune system of the subjects and interact with any viral infections
* evaluate the safety and influence of treatment with double dose of GAD-Alum (Diamyd) plus Vitamin D on the immune system, viral infections, and on preservation of residual insulin secretion in recently diagnosed Type 1 Diabetes

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

GAD-Alum (Diamyd) 20 µg

BIOLOGICAL

GAD-Alum (Diamyd) 20 µg X 2

DRUG

Vitamin D

DRUG

Ibuprofen

Sponsors & Collaborators

  • Swedish Child Diabetes Foundation

    collaborator OTHER

  • The Research Council of South East Sweden (FORSS)

    collaborator UNKNOWN

  • Diamyd Medical AB

    collaborator INDUSTRY

  • Johnny Ludvigsson

    lead OTHER_GOV

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2017-03-31
Completion
2017-03-31

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 NCT01785108 on ClinicalTrials.gov