Diagnosis and Physiopathology of Insulin Allergy

Diabetes Mellitus, Type 2 Clinical Trial

— Allerdiab  

Official title:

Diagnosis and Physiopathology of Insulin Allergy (IA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407640
• Other study ID #: P081223
• Status: Completed
• Phase: N/A
• First received: June 28, 2011
• Last updated: March 16, 2018
• Start date: February 6, 2012
• Est. completion date: July 27, 2016

Study information

• Verified date: March 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 27, 2016
• Est. primary completion date: July 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

Sola-Gazagnes A, Pecquet C, Radermecker R, Piétri L, Elgrably F, Slama G, Sélam 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. — View Citation

Sola-Gazagnes A, Pecquet C. [Allergy to insulin in 2003]. Journ Annu Diabetol Hotel Dieu. 2004:161-79. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of cutaneous insulin tests	Response of cutaneous insulin tests in patients with IA (Insulin Allergy) at study completion.	after 36 months
Secondary	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	after 36 months