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New treatment option for Type 1 Diabetes
Official title Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
ClinicalTrials.gov ID: NCT05153070
What this study is testing
What is Cyclosporin?
Cyclosporin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for type 1 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Type 1 diabetes (T1D) is caused by the destruction of insulin-producing cells by effector T cells (Teffs), due to a deficiency of regulatory T cells (Tregs). Ciclosporin effectively blocks the Teffs and controls diabetes, but cannot be considered as a long-term treatment.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 45
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.