Ciclosporin followed by low-dose IL-2 for newly diagnosed Type 1 diabetes
Clinical and Biological Responses to Repeated Administration of Low-dose Interleukin-2 in Patients With Type 1 Diabetes and a Residual Insulin Secretion
This study is testing whether using ciclosporin followed by low-dose IL-2 can help people recently diagnosed with Type 1 diabetes keep their insulin-producing cells and reduce their need for insulin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 16 Years to 45 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05153070 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of ciclosporin, an immunosuppressant, followed by low-dose interleukin-2 (IL-2) in patients recently diagnosed with Type 1 diabetes. The study aims to block the autoimmune process that destroys insulin-producing cells by using ciclosporin for two months, followed by IL-2 to activate regulatory T cells. The primary objective is to assess changes in regulatory T cell values after treatment, while secondary objectives include evaluating residual insulin secretion and insulin requirements over time. The trial is designed as a randomized, placebo-controlled, double-blind study.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 to 45 who have been diagnosed with Type 1 diabetes within the last three months and have at least one positive autoantibody.
Not a fit: Patients with a history of significant heart disease or those who have been diagnosed with Type 1 diabetes for more than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help restore immune balance and maintain insulin production in patients with Type 1 diabetes.
How similar studies have performed: Other studies have shown promise in using IL-2 to expand regulatory T cells, but this specific combination with ciclosporin is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Age at inclusion between ≥ 16 years old (Tanner 5 pubertal stage) and ≤ 45 years old * Type 1 diabetes according to ADA criteria, with at least 1 positive autoantibody among the following: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin. * Diagnosis ≤ 3 months * No acid ketosis * No weight loss \> 10% OR with fasting C-peptide ≥ 0.1 nmol/L (after a period of ≥ 15 days following the initiation of insulin therapy * Absence of clinically significant biological abnormalities on hematological, biochemical, hepatic, renal and thyroid tests. * No documented history of heart disease, no family history of sudden death, AND normal ECG. * Effective contraception in men and women of childbearing potential \> 2 weeks prior to first administration of the investigational drug and throughout the treatment period (if sexually active). Specifically for women of childbearing age and sexually active, they must use an effective contraceptive method (Pearl Index \< 1). The following methods are acceptable: oral hormonal contraceptives, injectable, or implanted (with the exception of oral minipills: i.e. low doses of gestagens which are not acceptable (lynestrenol and norestisteron), intrauterine contraceptives (e.g. progestin-release systems)), * Free, informed and written consent, signed by the patient and the investigator, prior to any examination required by the trial. If the patient is a minor, the signatures of both parents and of the child will be collected (or the legal representative if only one parent is alive). Exclusion Criteria: * Known contraindications to IL2 treatment: * Hypersensitivity to the active substance or to one of the excipients. * Signs of active infection requiring antibiotics * Documented history of clinical autoimmune disease * Oxygen saturation ≤ 90% * Existence of a serious dysfunction in a vital organ * History of organ allograft, * Known contraindications to treatment with cyclosporine * Presence of unauthorized treatment, i.e. cytotoxic drugs, products known for their impact on blood glucose levels or for their interactions with the treatments under trial * Patients who have received anti-diabetic treatment other than insulin for more than 3 consecutive months. * Anti-thyroperoxidase positive and abnormal TSH and 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 * Lymphopenia ≤ 1000/ mm3 * Presence or history of cancer that has been cured for less than five years, except in situ cervical or basal cell carcinoma in early stage management, * Participation in other intervention research involving humans \< 3 months, * Pregnant or breastfeeding women * Lack of social security affiliation (as a beneficiary or assignee) * Vaccination with live attenuated virus during the last 4 weeks before the start of the experimental treatment and during the entire treatment phase. * Patient with active SARS-CoV-2 infection * Patient with chronic respiratory disease * Subject under legal protection (such as tutorship, curatorship, or judicial safeguard) * Subject hospitalized without consent, unable to express consent or deprived of liberty
Where this trial is running
Paris
- Lorenzon Roberta — Paris, France (Recruiting)
Study contacts
- Principal investigator: Agnès Hartmann, MD, Ph.D — Aphp(assistance Publique Des Hopitaux de Paris
- Study coordinator: David Klatzmann, MD, Ph.D
- Email: david.klatzmann@sorbonne-universite.fr
- Phone: 01 42 17 74 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.