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Clinical Trial Details

Trial ID: L5144
Source ID: NCT00711503
Associated Drug: Anakinra
Title: Anti-Interleukin-1 in Diabetes Action
Acronym: AIDA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: anakinra|DRUG: saline
Outcome Measures: Primary: Δ 2-h AUC C-peptide response, 1 month, 3 months, 6 months, 9 months | 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
Sponsor/Collaborators: Sponsor: Steno Diabetes Center Copenhagen | Collaborators: Juvenile Diabetes Research Foundation|Oeresund Diabetes Academy
Gender: ALL
Age: ADULT
Phases: PHASE2|PHASE3
Enrollment: 69
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-01
Completion Date: 2012-06
Results First Posted:
Last Update Posted: 2012-09-03
Locations: Aalborg Hospital, Aalborg, 9100, Denmark|Aarhus Universitetshospital, Aarhus, 8000 C, Denmark|Bispebjerg Universitetshospital, Copenhagen, 2400 NV, Denmark|Steno Diabetes Center, Gentofte, 2820, Denmark|Nordsjællands Hospital, Hillerød, Hillerød, 3400, Denmark|Ulm University, Dept. of Internal Medicine, Ulm, Donau, 89081, Germany|Leibniz Center for Diabetes research, Heinrich-Heine University, Duesseldorf, 40225, Germany|University of Frankfurt am Main, Frankfurt am Main, 60590, Germany|Institut für Diabetesforschung, Munich University of Technology, Munich, 80804, Germany|University Campus Bio-Medico, Rome, 00128, Italy|Leiden University Medical Center, Leiden, 2300 RC, Netherlands|Medical University of Bialystok, Bialystok, 15-269, Poland|Hospital de Cruces, Diabetes Research Group, Barakaldo, Bizkaia, 48903, Spain|Hospital Unversitario Insular de Gran Canaria, Las Palmas, Gran Canaria, 35016, Spain|Hospital Santa Creu i Sant Pau, Barcelona, 08025, Spain|Hospital Arnua de Vilanova, Lleida, 25198, Spain|University Hospital Zürich, Zürich, CH-8091, Switzerland
URL: https://clinicaltrials.gov/show/NCT00711503