Status:
COMPLETED
Anti-Interleukin-1 in Diabetes Action
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Oeresund Diabetes Academy
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
PHASE3
Brief Summary
A draw trial of the effect of Interleukin-1 Receptor Antagonist (anakinra, Kineret®) on the insulin production in patients with new onset Type 1 diabetes. Kineret® is already being used in the treatm...
Detailed Description
Objectives: 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 enhan...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00711503
Start Date
January 1 2009
End Date
June 1 2012
Last Update
September 3 2012
Active Locations (17)
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1
Aalborg Hospital
Aalborg, Denmark, 9100
2
Aarhus Universitetshospital
Aarhus, Denmark, 8000 C
3
Bispebjerg Universitetshospital
Copenhagen, Denmark, 2400 NV
4
Steno Diabetes Center
Gentofte Municipality, Denmark, 2820