type 1 diabetes
Conditions
Interventions
The patients are instructed to administer anti-IL-1 therapy in the form of
recombinant human non-glycosylated interleukin-1 receptor antagonist (anakinra)
at a dose of 100 mg once daily or placebo b
Sponsors
Steno Diabetes Center
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Type 1 diabetes diagnosis
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is beta-cell function assessed as C-peptide response to a standardized 2-h mixed-meal test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include insulin requirement, percent insulin-free remission, and 2h glucose levels after the mixed meal test. | — |
Countries
Netherlands
Outcome results
None listed