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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01407640
Other study ID # P081223
Secondary ID
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
Health authority
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

Study Design


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
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