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Diagnosis and Physiopathology of Insulin Allergy

NCT01407640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-09-12

No results posted yet for this study

Summary

Insulin allergy (IA) is still observed even with recombinant human insulin and insulin analogs.

Obviously, the usual attitude facing an allergy, i. e. exclusion of the allergen, poses problems in face of IA because insulin is often vital for the patient. IA is thus a complex situation in which a rigorous diagnostic procedure to identify the exact allergen is necessary to propose a therapeutic answer; the purpose of the study is 1/ to validate a diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Hypersensitivity
  • Immediate Hypersensitivity
  • Allergy

Interventions

PROCEDURE

Allergy tests

1/ to validate a diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Agnes Sola-Gazagnes, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-06
Primary Completion
2016-07-27
Completion
2016-07-27

Countries

  • France

Study Locations

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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 NCT01407640 on ClinicalTrials.gov