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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT00711503
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes diagnosed according to WHO 1999 criteria
* Positive GAD auto-antibodies
* Age 18-35 yrs at onset of diabetes
* Time from first symptoms of diabetes \< 12 weeks
* Peak C-peptide more than or equal to 200 pM after a standardized mixed meal test (Boost) at a test carried out when the subject is metabolically stable, i.e. after resolution of any polyuria, polydypsia or ketoacidosis.
Exclusion Criteria:
* Severe liver or renal disease (creatinine \> 100 μmol/L, ASAT/ALAT \> 2\* ULN, alkaline phosphatase \> 2 \* ULN)
* History of heart disease, signs of cardiac failure or abnormal ECG
* Present or previous malignancy
* Pregnancy or failure of fertile female to comply with contraceptional planning, or breast-feeding. (Safe contraceptive methods include birth control pills, IUD, and gestagen implants) . Plans of pregnancy within 2 years.
* Participation in other clinical intervention studies
* Anti-inflammatory therapy (except aspirin £ 100 mg/d)
* Active infections (CRP\>30), history of recurrent infection or predisposition to infections
* Neutropenia: ANC \< 1.5\*109/L, or anaemia: Haemoglobin \< 8.0 g/dL
* Immune-suppressive treatment or immune-deficiency
* Presence at diagnosis of late diabetic complications
* Concurrent vaccination with live vaccine. Known need for live vaccinations within 2 years.
* Use of Etanercept within 6 months before screening or during the double-blinded study period
* Hypersensitivity to E. coli-derived proteins, anakinra or any components of the product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT00711503
Study Brief:
Protocol Section:
NCT00711503