Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT02803892
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged \>18 years, inclusive
* Clinical history compatible with T1D with onset of disease at \< 40 years of age, insulin dependence for ≥ 5 years at the time of enrolment
* C-peptide concentrations under the threshold of preserved beta cell function: fasting C peptide \<0.23 ng/ml
* Detectable fasting proinsulin concentrations (\>0.5 pmol/l)
* Ability to provide written informed consent
* Mentally stable and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations
Exclusion Criteria:
* Body mass index (BMI) \>30 kg/m2 or patient with body weight ≤40kg;
* Insulin requirement \>1.0 IU/kg/day or \<10 U/day;
* HbA1c \>11% (normal value: 3.5-6.0%) at the time of enrolment
* estimated glomerular filtration rate \<60 mL/min/1.73m2 calculated using the subject's measured serum creatinine and the Modification of Diet in Renal Disease \[MDRD\] study estimation formula)
* Presence or history of macroalbuminuria (\>300mg/g creatinine)
* For female subjects: positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation of treatment
* Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB) as determined by a positive skin test or clinical presentation, or under treatment for suspected TB
* Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
* Lymphopenia (\<1,000/μL), neutropenia (\<1,500/μL), or thrombocytopenia (platelets \<100,000/μL).
* Severe unremitting diarrhea, vomiting or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications
* Any medical condition that will interfere with safe participation in the trial;
* Any immunosuppressive treatment at the time of enrollment.
* Allergy to active ingredients or to any of excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02803892
Study Brief:
Protocol Section:
NCT02803892