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Completed

NCT Number: NCT01407640

Diagnosis and Physiopathology of Insulin Allergy

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Allergy Autoimmune Diseases Chemically-Induced Disorders Diabetes Mellitus Diabetes Mellitus, Type 2 Drug-Related Side Effects and Adverse Reactions Endocrine System Diseases Glucose Metabolism Disorders Hypersensitivity Hypersensitivity, Immediate Immediate Hypersensitivity Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochin Hospital

Paris, 75005, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allergy tests

Procedure

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

  1. Validation of cutaneous insulin tests

    Time frame: after 36 months

    Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion.

Secondary outcomes

  1. Immunogenetic of patients with IA (Insulin Allergy)

    Time frame: after 36 months

    Immunogenetic of patients with IA (Insulin Allergy) at study completion Determination of insulin epitopes that are involved in IA at study completion Determination of isotypes of anti insulin antibodies and whether specific isotypes are associated with susceptibility / protection at study completion

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Diagnosis and Physiopathology of Insulin Allergy (IA)

Acronym: Allerdiab

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2011
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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