NCT01285245

Brief Summary

The purpose of this study is to test whether anakinra is able to reduce insulin resistance. This will be tested in overweighted type I diabetes mellitus patients, which have no residual beta-cell function. By using this patient group, all positive effects on glycemic control should be the consequence of improved insulin sensitivity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_2 diabetes-mellitus

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_2 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 14, 2011

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

November 26, 2010

Last Update Submit

April 13, 2011

Conditions

Diabetes Mellitus

Keywords

insulin sensitivityinterleukin-1 receptor antagonistinflammationhyperglycemia-induced insulin resistance

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity as determined by euglycemic hyperinsulinemic clamp

    insulin sensitivity measured by euglycemic hyperinsulinemic clamp

    change in insulin sensitivity after 1 week of treatment with anakinra as compared to baseline

Secondary Outcomes (4)

  • glycemic control

    baseline, after 1 week of treatment and 4 weeks after treatment termination

  • adipocyte insulin sensitivity

    baseline, after 1 week of treatment, 4 weeks after treatment termination

  • circulating hormonal and inflammatory factors and lipid profile

    baseline, after 1 week of treatment, 4 weeks after treatment termination

  • insulin sensitivity as determined by euglycemic hyperinsulinemic clamp

    change in insulin sensitivity 4 weeks after stopping anakinra treatment as compared to baseline

Study Arms (1)

kineret

EXPERIMENTAL
Drug: kineret

Interventions

kineretDRUG

once daily 100 mg of kineret subcutaneously for 8 days

Also known as: anakinra, interleukin-1 receptor antagonist
kineret

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes for more than 5 years
  • Body mass index of \> 25 kg/m2
  • Insulin requirement \> 0.5 U/kg bodyweight
  • HbA1c\>7.5%, stable glycemic control

You may not qualify if:

  • Inability to give informed consent
  • Presence of any medical condition that might interfere with the current study protocol.
  • Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
  • Anti-inflammatory drugs (including nonsteroidal anti-inflammatory drugs, 100 mg or less of aspirin per day is allowed)
  • Signs of current infection (fever, C-reactive protein (CRP) \> 30 mmol/l, treatment with antibiotics, previous or current diagnosis of tuberculosis.
  • A history of recurrent infections
  • Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
  • Renal disease (creatinine \> 130 µmol/l
  • Neutropenia \< 2 x 109/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusInsulin ResistanceInflammation

Interventions

Interleukin 1 Receptor Antagonist ProteinReceptors, Interleukin-6

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsReceptors, InterleukinReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Cees J Tack, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edwin JP van Asseldonk, MD

CONTACT

+31243619857e.vanasseldonk@aig.umcn.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2010

First Posted

January 27, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

April 14, 2011

Record last verified: 2010-11

Locations

NL(1)