E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 11 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Δ 2-h AUC C-peptide response between baseline and 9 months
Secondary endpoints include: Δ Incremental and/or peak C-peptide response Δ Time to peak C-peptide Δ insulin requirement per kg body weight per day Δ frequency of insulin free state with maintenance of HbA1c <7.5% Δ HbA1c and Δ FPG, although as mentioned investigators should strive to optimize glycaemia to the same level in both treatment arms Δ Means of fasting glucose values Δ Circulating IL-6 and CRP |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |