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Diabetes Prevention - Immune Tolerance

NCT01122446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-05-06

Study results available
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Summary

A double-blind, randomized investigator-initiated study to determine the safety and the effect of Diamyd® on the progression to type 1 diabetes in children with multiple islet cell autoantibodies

Eligible children are 4 years or older, have positive GAD-antibodies and at least one additional autoantibody and not yet diabetes.

Objectives:

DiAPREV-IT is the first prevention study with Diamyd®, where the drug is given before onset of type 1 diabetes.

The primary objective is to demonstrate that Diamyd® is safe in children at risk for type 1 diabetes.

The secondary objective is to evaluate if Diamyd® may delay or stop the autoimmune process leading to clinical type 1 diabetes in children with ongoing persistent beta-cell autoimmunity as indicated by multiple positive islet cell autoantibodies.

Conditions

Interventions

OTHER

Placebo comparator

Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies. Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo.

DRUG

Diamyd

20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies. Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd

Sponsors & Collaborators

  • Region Skane

    collaborator OTHER

  • Lund University

    lead OTHER

Principal Investigators

  • Helena Elding Larsson, MD, PhD · Region Skåne and Lund University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT01122446 on ClinicalTrials.gov