DFIL2-REP - Study of the clinical and biological response to repeated administration of low-dose interleukin-2 in patients with type 1 diabetes who have retained residual insulin secretio
- Conditions
- Patient with newly diagnosed (= 3 months) type 1 diabetes stage 3Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2024-514043-29-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Age at inclusion between = 16 years (Tanner 5 pubertal stage) and = 45 years, Type 1 diabetes according to ADA criteria, with at least 1 positive autoantibody (AAC) among the following AACs: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin, Diabetes stage 3 = 3 months and without ketoacidosis and without weight loss > 10% OR with fasting C-peptide = 0.1nmol/L (after a delay = 15days following initiation of insulin therapy)., Absence of clinically significant biological abnormalities in hematology, biochemistry, liver, kidney and thyroid function tests, No documented history of heart disease and ECG without clinically significant abnormalities, Effective contraception for men and women of childbearing age > 2 weeks before the first administration of the investigational drug and throughout the treatment period (if sexually active). Sexually active women of childbearing age must use an effective contraceptive method. The following methods are acceptable: oral, injectable or implanted hormonal contraceptives. The minipill and copper IUD are tolerated28, Free, informed and written consent, signed by the patient and the investigator, before any examination required by the trial. If the patient is a minor, the signatures of the 2 parents and the child will be collected (or the legal representative if only one parent is alive).
Known contraindications to IL-2 therapy, Lymphopenia = 1000/ mm3, Presence or history of cancer cured within the last five years, except in situ cervical cancer or basal cell cancer managed at an early stage, Participation in other research relating to a clinical trial of a medicinal product for human use< 3 months, Pregnant or breast-feeding women, No social security coverage (as beneficiary or beneficiary's beneficiary), Vaccination with live attenuated virus in the last 4 weeks before starting experimental treatment and throughout the treatment phase, Patient with active SARS-CoV-2 infection, Patients with chronic respiratory disease, Subject under legal protection (such as guardianship, curatorship or safeguarding), Subject hospitalized without consent, unable to express consent or deprived of liberty, Known contraindications to ciclosporin treatment, Presence of unauthorized treatments, i.e. cytotoxics, products known to have an impact on glycemia or to interact with trial treatments, Patients who have received anti-diabetic treatment other than insulin for more than 3 consecutive months, Positivity of at least one thyroid-specific antibody (anti-TPO, anti-TG or anti-TRAKS) associated with an abnormal thyroid workup (TSH, T3, or T4) at inclusion, Anti-transglutaminase positive at inclusion, EBV viral load > 2000 IU/ml, CMV viral load > 400 IU/ml, HBV, HCV or HIV infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method