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Anti-Interleukin-1 in Diabetes Action

NCT00711503 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2012-09-03

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

anakinra

The patients are instructed to administer anti-IL-1 therapy in the form of recombinant human non-glycosylated interleukin-1 receptor antagonist (IL-1Ra, anakinra, Kineret®, Amgen, CA, USA) \[13\] at a dose of 100 mg once daily by subcutaneous injection

DRUG

saline

The patients are instructed to administer placebo (saline) once daily by subcutaneous injection

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Oeresund Diabetes Academy

    collaborator UNKNOWN

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Thomas R Mandrup-Poulsen, MD, DMSc · Steno Diabetes Center Copenhagen

  • Marc Donath · Universtity of Zürich

  • Flemming Pociot, DMSc · Steno Diabetes Center Copenhagen

  • Charles Dinarello · University of Colorado Health Science Center

  • Edwin Gale, Professor · Bristol University, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-01-31
Completion
2012-06-30

Countries

  • Denmark
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00711503 on ClinicalTrials.gov