Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 1, diabetes mellitus, type 2, hypersensitivity, immediate hypersensitivity, allergy
Treatment allergy tests
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Institut National de la Santé Et de la Recherche Médicale, France
Start date February 2012
End date December 2016
Trial size 55 participants
Trial identifier NCT01407640, P081223

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Allergy tests
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

Primary Outcomes

Measure
Validation of cutaneous insulin tests
time frame: after 36 months

Secondary Outcomes

Measure
Immunogenetic of patients with IA (Insulin Allergy)
time frame: after 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria : - Patients aged 18 years old and more with a written informed consent - Experimental group : type 1 or type 2 diabetic patients with insulin allergy based on clinical criteria - Active Comparator group: type 1 or type 2 diabetic patients insulin treated without insulin allergy Exclusion criteria : - Not willing participate - Pregnancy - Age below 18 years - Severe Renal failure - Severe Anaphylactic shock only for the experimental group - No social security overture

Additional Information

Official title Diagnosis and Physiopathology of Insulin Allergy (IA)
Principal investigator Agnes Sola-Gazagnes, MD
Description Phenotype of the patient Investigation of allergy per intradermal testing using a wide range of insulin preparations Determination of immunologic and immunogenetic profile particularly CD4 + T cells and mast cells
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.