The Anti-Interleukin-1 in Diabetes Action trial
- Conditions
- type 1 diabetes10018424
- Registration Number
- NL-OMON32562
- Lead Sponsor
- Steno Diabetes Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Type 1 diabetes diagnosis <12 weeks
positive GAD antibodies
18-35 years old
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is beta-cell function assessed as C-peptide response to a<br /><br>standardized 2-h mixed-meal test. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include insulin requirement, percent insulin-free<br /><br>remission, and 2h glucose levels after the mixed meal test.</p><br>