European phase-II clinical trial evaluating efficacy of low dose rhIL-2 in patients with recently diagnosed type 1 diabetes - DIABIL-2

Assistance Publique - Hôpitaux de Paris (AP-HP)0 个研究点目标入组 138 人开始时间: 2014年12月10日最近更新: 2021年8月2日

适应症

试验速览

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•-Age 6-35 years, except for Germany, Belgium and Netherlands.
•-Male or female both using effective methods of contraception during treatment if sexually active
•-With type-1 diabetes
•-Newly diagnosed (ADA criteria) at most two months between insulin initiation and anticipated start of experimental treatment
•-Positive for one or more of the autoantibodies typically associated with T1D
•-With a detectable peak C-peptide concentration during a standardised MMTT (= 0.2pmol/ml)
•-Patients with a stable blood glucose level and seric glycemia between 60 mg/dL and 250 mg/dL verified at MMTT visit
•-Absence of clinically significant abnormal laboratory values in haematology, biochemistry, thyroid, liver and kidney function;
•-Normal cardiac function
•-Efficient contraception for potentially child-bearing patients
•-Free, informed and written consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 92
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 46
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Children under the age of 12 years old cannot be included In Germany, Belgium and Netherlands
•- In case of ketoacidosis at diabetes diagnosis : Venous pH=7.25 or undue ketonuria at diabetes diagnosis
•- Chronic adrenal insufficiency known or fasting ACTH =2.5 ULN normal at inclusion after control
•- Anti TPO present at inclusion and abnormal TSH
•- Anti-transglutaminase positive at inclusion
•- Hypersensitivity to the active substance or to any of the excipients
•- Any major health problem including asthma requiring treatment by corticosteroids (whatever route of administration) and including serious digestive malfunctions.
•- 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
•- Children or adolescents with obesity grade>2, adult with BMI = 35
•- Existence of a serious malfunction of a vital organ
•- History of organ allograft
•- Use of treatments not allowed in the Study
•- Vaccination with alive attenuated virus within 4 weeks
•- 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)

发起方

Assistance Publique - Hôpitaux de Paris (AP-HP)