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A Randomised Clinical Trial of the Effect of Interleukin-1 Receptor Antagonism on the Insulin Production in Patients With New Onset Type 1 Diabetes

This study is currently Recruiting

December 2009 By Steno Diabetes Center

First Recieved on July 3, 2008

Last Updated on August 2, 2010

Sponsor: Steno Diabetes Center
Collaborators: Juvenile Diabetes Research Foundation
Information provided by: Steno Diabetes Center
Identifier: NCT00711503

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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 ?mol/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.

Investigators

  • Investigator: Thomas R Mandrup-Poulsen, MD, DMSc - Principal Investigator - Steno Diabetes Center
  • Investigator: Marc Donath - Study Director - Universtity of Z?rich
  • Investigator: Flemming Pociot, DMSc - Study Director - Steno Diabetes Center
  • Investigator: Charles Dinarello - Study Director - University of Colorado Health Science Center
  • Investigator: Edwin Gale, Professor - Study Chair - Bristol University, UK

Locations

  • Aalborg Hospital

    Aalborg, 9100 Denmark

  • Aarhus Universitetshospital

    Aarhus, 8000 C Denmark

  • Bispebjerg Universitetshospital

    Copenhagen, 2400 NV Denmark

  • Steno Diabetes Center

    Gentofte, 2820 Denmark

  • Nordsj?llands Hospital, Hiller?d

    Hiller?d, 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 f?r 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 Z?rich

    Z?rich, CH-8091 Switzerland

Conditions related to this trial:

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