NCT01407640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

February 6, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2016

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

4.5 years

First QC Date

June 28, 2011

Last Update Submit

September 5, 2025

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2HypersensitivityImmediate HypersensitivityAllergy

Keywords

Insulin allergyadverse drug reactiondiabetestype 1 hypersensitivityimmediate hypersensitivitytype 4 hypersensitivityinsulin analogsintradermal testinginsulin antibodymast cellCD+ TCELL

Outcome Measures

Primary Outcomes (1)

  • Validation of cutaneous insulin tests

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

    after 36 months

Secondary Outcomes (1)

  • Immunogenetic of patients with IA (Insulin Allergy)

    after 36 months

Study Arms (1)

1

EXPERIMENTAL

Allergy tests

Procedure: Allergy tests

Interventions

Allergy testsPROCEDURE

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not willing participate
  • Pregnancy
  • Age below 18 years
  • Severe Renal failure
  • Severe Anaphylactic shock only for the experimental group
  • No social security overture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75005, France

Location

Related Publications (4)

  • 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.

    PMID: 35505238BACKGROUND

  • 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.

    PMID: 14514615BACKGROUND

  • Sola-Gazagnes A, Pecquet C. [Allergy to insulin in 2003]. Journ Annu Diabetol Hotel Dieu. 2004:161-79. No abstract available. French.

    PMID: 15259314BACKGROUND

  • 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.

    PMID: 17321300BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2HypersensitivityHypersensitivity, ImmediateDrug-Related Side Effects and Adverse ReactionsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesChemically-Induced Disorders

Study Officials

  • Agnes Sola-Gazagnes, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2011

First Posted

August 2, 2011

Study Start

February 6, 2012

Primary Completion

July 27, 2016

Study Completion

July 27, 2016

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

FR(1)