The Anti-Interleukin-1 in Diabetes Action trial - AIDA

Conditions: new-onset 1 diabetes
MedDRA version: 11Level: LLTClassification code 10067584Term: <Manually entered code. Term in E.1.1>

Registration Number: EUCTR2007-007146-34-DE

Lead Sponsor: Steno Diabetes Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 breastfeeding. (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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the Anti-Interleukin-1 in Diabetes Action trial (AIDA) study is to test the feasibility, safety/ tolerability and potential efficacy of anti-IL-1 therapy in maintaining or enheancing beta-cell function in people with new-onset Type 1 diabetes.;Secondary Objective: ;Primary end point(s): ? 2-h AUC C-peptide response between baseline and 9 months<br><br>Secondary endpoints include:<br>? Incremental and/or peak C-peptide response<br>? Time to peak C-peptide<br>? insulin requirement per kg body weight per day<br>? frequency of insulin free state with maintenance of HbA1c <7.5%<br>? HbA1c and ? FPG, although as mentioned investigators should strive to optimize glycaemia to the same level in both treatment arms<br>? Means of fasting glucose values<br>? Circulating IL-6 and CRP

Secondary Outcome Measures