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Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree Relatives

NCT00654121 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2008-04-07

No results posted yet for this study

Summary

Prophylactic administration of metabolically active insulin can prevent or delay clinical onset of diabetes in a high risk group of nondiabetic siblings as defined by positivity for autoantibodies against IA-2 (IA-2-A).

Conditions

  • Diabetes, Type I

Interventions

DRUG

Actrapid HM

56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)

Sponsors & Collaborators

Principal Investigators

  • Frans Gorus, MD,PhD · Universitair Ziekenhuis Brussel

  • Evy Vandemeulebroucke, MD · Universitair Ziekenhuis Brussel

Study Design

Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2004-04-30
Completion
2007-11-30

Countries

  • Belgium

Study Locations

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Entities

Companies

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 NCT00654121 on ClinicalTrials.gov