Type 1 Diabetes Clinical Trial
— AIDAOfficial title:
A Randomised Clinical Trial of the Effect of Interleukin-1 Receptor Antagonism on the Insulin Production in Patients With New Onset Type 1 Diabetes
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 treatment of patients suffering from rheumatoid
arthritis and preclinical studies are now suggesting that it may also be useful for patients
with Type 1 diabetes. The active substance in Kineret is interleukin-1 receptor antagonist,
a blocker of an immune-signal molecule named interleukin-1.
The trial is a blinded randomised trial, in which the patient is allocated to receive the
active drug (Kineret®) or placebo (saline). The hypothesis is that anti-IL-1 treatment as
add-on therapy to conventional insulin therapy will preserve or enhance beta-cell function.
Status | Completed |
Enrollment | 69 |
Est. completion date | June 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
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. 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 < 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg Hospital | Aalborg | |
Denmark | Aarhus Universitetshospital | Aarhus | |
Denmark | Bispebjerg Universitetshospital | Copenhagen | |
Denmark | Steno Diabetes Center | Gentofte | |
Denmark | Nordsjællands Hospital, Hillerød | Hillerød | |
Germany | Leibniz Center for Diabetes research, Heinrich-Heine University | Duesseldorf | |
Germany | University of Frankfurt am Main | Frankfurt am Main | |
Germany | Institut für Diabetesforschung, Munich University of Technology | Munich | |
Germany | Ulm University, Dept. of Internal Medicine | Ulm | Donau |
Italy | University Campus Bio-Medico | Rome | |
Netherlands | Leiden University Medical Center | Leiden | |
Poland | Medical University of Bialystok | Bialystok | |
Spain | Hospital de Cruces, Diabetes Research Group | Barakaldo | Bizkaia |
Spain | Hospital Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital Unversitario Insular de Gran Canaria | Las Palmas | Gran Canaria |
Spain | Hospital Arnua de Vilanova | Lleida | |
Switzerland | University Hospital Zürich | Zürich |
Lead Sponsor | Collaborator |
---|---|
Steno Diabetes Center | Juvenile Diabetes Research Foundation, Oeresund Diabetes Academy |
Denmark, Germany, Italy, Netherlands, Poland, Spain, Switzerland,
Pickersgill LM, Mandrup-Poulsen TR. The anti-interleukin-1 in type 1 diabetes action trial--background and rationale. Diabetes Metab Res Rev. 2009 May;25(4):321-4. doi: 10.1002/dmrr.960. Review. Erratum in: Diabetes Metab Res Rev. 2009 Nov;25(8):780. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ? 2-h AUC C-peptide response | 1 month, 3 months, 6 months, 9 months | No | |
Secondary | 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, Means of fasting glucose values, circulating IL-6 and CRP | 1 month, 3 months, 6 months, 9 months | No |
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