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GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1)

NCT02352974 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-04-27

Study results available
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Summary

The objectives of the main study is to:

* Evaluate the safety of giving GAD-Alum (Glutamic acid decarboxylase) (Diamyd) directly into lymph glands in combination with an oral vitamin D regimen
* Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion.

The objective of the sub-study is to:

* Evaluate safety after a fourth injection with 4 μg GAD-Alum direct into an inguinal lymph gland in 3 adult patients from the main study
* Evaluate how the above mentioned treatment influences the immune system and endogenous insulin secretion.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

GAD-Alum

DRUG

Vitamin D

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, Professor · Linkoeping University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-10-31
Completion
2019-10-31

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 NCT02352974 on ClinicalTrials.gov