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This study examined the effect of low-dose rhIL-2 compared with placebo in patients with recently diagnosed type 1 diabetes. It included patients aged 6 to 35 diagnosed within the past three months and carrying the relevant autoantibodies. It was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion criteria * Age 6-35 years old. * Male or female both using effective methods of contraception during treatment if sexually active. * Specifically; Females (if sexually active) with childbearing potential must use contraceptive methods that are considered as highly-effective (pearl index \< 1). The following methods are acceptable: Oral , injectable, or implanted hormonal contraceptives (with the exception of oral minipills ie low-dose gestagens which are not acceptable (lynestrenol and norestisteron), Intrauterine device, Intrauterine system (for example, progestin-releasing toit), * beta HCG negative at inclusion; * With type-1 diabetes: * Newly diagnosed (ADA criteria, see annexe 19.6) at most three months between insulin initiation and anticipated start of experimental treatment. * Positive for one or more of the autoantibodies typically associated with T1D (anti-islet, -insulin, -GAD, -IA2, -ZnT8) * With a detectable peak C-peptide concentration during a standardised MMTT at Visit MMTT (≥0.2pmol/ml); * patients with a stable blood glucose level and seric glycaemia between 60 mg/dL and 250 mg/dL verified at MMTT visit * Absence of clinically significant abnormal laboratory values (out of range and associated with clinical symptoms or signs) in haematology, biochemistry, thyroid, liver and kidney function; * Normal cardiac function: no documented history of heart disease and absence of family history of sudden death, normal ECG especially QTc duration within normal value (\<480ms); * Free, informed and written consent, signed by the patient and investigator before any Study examination. If the patient is a minor by child and both parents or child and the legal representative in case only one parent is alive. (Journal officiel des communautés européennes (1.5.2001) * NB: patient with history of thyroidism on treatment at the inclusion and with normal thyroid hormone values (TSH+T4) can be included. Exclusion criteria * Children under the age of 6 years old cannot be included * Patient who, before inclusion, have been treated with other anti-diabetic medication than Insulin for more than 3 months consecutively * Chronic adrenal insufficiency known or fasting ACTH ≥2.5 ULN normal at inclusion after control; * Anti TPO present at inclusion and abnormal TSH and T4 * Anti-transglutaminase positive at inclusion * Hypersensitivity to the active substance or to any of the excipients * Any major health problem including: any major auto-immune/auto-inflammatory disease (other than type 1 diabetes) present at inclusion, any significant respiratory disease (such as moderate or severe COPD or asthma) requiring the chronic use of corticosteroids (whatever route of administration) and serious digestive malfunctions. * Patient with existing malignancy or history of malignancy * Major psychosocial instability with expected lack of compliance with insulin treatment, psychiatric pathology of patient or parents, or major problems of family dynamics; * Signs of active infection; * Any patient with obesity defined as BMI ≥ 35 * Existence of a serious malfunction of a vital organ; * History of organ allograft; * Use of treatments not allowed in the Study (see Section 8.4.2); * Vaccination with alive attenuated virus within 4 weeks of the first injection of the induction period and during the whole maintenance period * Pregnant female (confirmed by laboratory testing) or lactating * Participation in another clinical trial in the previous 3 months; * Lack of affiliation to a social security scheme (as a beneficiary or assignee).