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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004434-24-NL

Enrollment

160

Registered

2008-12-09

Start date

2008-10-13

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

new-onset Type 1 diabetes MedDRA version: 9.1 Level: LLT Classification code 10012594 Term: Diabetes

Interventions

Trade Name: Kineret Product Name: Kineret Product Code: anakinra, r-metHuIL-1ra Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 1 diabetes diagnosed according to WHO 1999 criteria Positive GAD and/or IA-2 auto-antibodies Age 18-35 yrs at onset of diabetes Time from first symptoms of diabetes =65 years) no F.1.3.1 Number of subjects for this age range

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) Participation in other clinical intervention studies Anti-inflammatory therapy (except aspirin < 100 mg/d) Active infections, 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 Use of Etanercept within 4 weeks before screening or during the double-blinded study period Hypersensitivity to E. coli-derived proteins, anakinra or any components of the product

Design outcomes

Primary

Measure	Time frame
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 enhancing 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 Secondary endpoints include: ? Incremental and/or peak C-peptide response ? Time to peak C-peptide ? insulin requirement per kg body weight per day ? frequency of insulin free state with maintenance of HbA1c <7.5% ? HbA1c and ? FPG, although as mentioned investigators should strive to optimize glycae-mia to the same level in both treatment arms ? Means of fasting and post-prandial home-plasma glucose monitoring values ? Circulating IL-6 and CRP	—

Measure

Time frame

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 enhancing 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 Secondary endpoints include: ? Incremental and/or peak C-peptide response ? Time to peak C-peptide ? insulin requirement per kg body weight per day ? frequency of insulin free state with maintenance of HbA1c <7.5% ? HbA1c and ? FPG, although as mentioned investigators should strive to optimize glycae-mia to the same level in both treatment arms ? Means of fasting and post-prandial home-plasma glucose monitoring values ? Circulating IL-6 and CRP

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026