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Diagnosis and Physiopathology of Insulin Allergy (Allerdiab)

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Allergy tests
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 1 focused on measuring Insulin allergy, adverse drug reaction, diabetes, type 1 hypersensitivity, immediate hypersensitivity, type 4 hypersensitivity, insulin analogs, intradermal testing, insulin antibody, mast cell, CD+ TCELL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cochin Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Allergy tests

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immunogenetic of patients with IA (Insulin Allergy)
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

Full Information

First Posted
June 28, 2011
Last Updated
March 16, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01407640
Brief Title
Diagnosis and Physiopathology of Insulin Allergy
Acronym
Allerdiab
Official Title
Diagnosis and Physiopathology of Insulin Allergy (IA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 6, 2012 (Actual)
Primary Completion Date
July 27, 2016 (Actual)
Study Completion Date
July 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Hypersensitivity, Immediate Hypersensitivity, Allergy
Keywords
Insulin allergy, adverse drug reaction, diabetes, type 1 hypersensitivity, immediate hypersensitivity, type 4 hypersensitivity, insulin analogs, intradermal testing, insulin antibody, mast cell, CD+ TCELL

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Allergy tests
Intervention Type
Procedure
Intervention Name(s)
Allergy tests
Intervention Description
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 Outcome Measure Information:
Title
Validation of cutaneous insulin tests
Description
Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion.
Time Frame
after 36 months
Secondary Outcome Measure Information:
Title
Immunogenetic of patients with IA (Insulin Allergy)
Description
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
Time Frame
after 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Sola-Gazagnes, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75005
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
14514615
Citation
Sola-Gazagnes A, Pecquet C, Radermecker R, Pietri L, Elgrably F, Slama G, Selam JL. Successful treatment of insulin allergy in a type 1 diabetic patient by means of constant subcutaneous pump infusion of insulin. Diabetes Care. 2003 Oct;26(10):2961-2. doi: 10.2337/diacare.26.10.2961. No abstract available.
Results Reference
background
PubMed Identifier
15259314
Citation
Sola-Gazagnes A, Pecquet C. [Allergy to insulin in 2003]. Journ Annu Diabetol Hotel Dieu. 2004:161-79. No abstract available. French.
Results Reference
background
PubMed Identifier
17321300
Citation
Sola-Gazagnes A, Pecquet C, M'Bemba J, Larger E, Slama G. Type I and type IV allergy to the insulin analogue detemir. Lancet. 2007 Feb 24;369(9562):637-8. doi: 10.1016/S0140-6736(07)60301-8. No abstract available.
Results Reference
background
PubMed Identifier
35505238
Citation
Sola-Gazagnes A, Pecquet C, Berre S, Achenbach P, Pierson LA, Virmoux-Buisson I, M'Bemba J, Elgrably F, Moguelet P, Boitard C, Caillat-Zucman S, Laanani M, Coste J, Larger E, Mallone R. Insulin allergy: a diagnostic and therapeutic strategy based on a retrospective cohort and a case-control study. Diabetologia. 2022 Aug;65(8):1278-1290. doi: 10.1007/s00125-022-05710-9. Epub 2022 May 4.
Results Reference
derived

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Diagnosis and Physiopathology of Insulin Allergy

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