The Effect of Anakinra on Insulin Secretion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285232
Recruitment Status : Unknown
Verified September 2010 by Radboud University.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2011
Last Update Posted : March 26, 2012
Information provided by (Responsible Party):
Radboud University

November 8, 2010
January 27, 2011
March 26, 2012
January 2011
March 2012   (Final data collection date for primary outcome measure)
To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps . [ Time Frame: after 4 weeks of treatment with anakinra ]
Same as current
Complete list of historical versions of study NCT01285232 on Archive Site
  • To determine the effect on anakinra on insulin sensitivity. [ Time Frame: after 4 week treatment of anakinra ]
    Oral glucose tolerance test
  • Effects of anakinra on fat cell morphology and gene expression [ Time Frame: after 4 weeks of treatment with anakinra ]
Same as current
Not Provided
Not Provided
The Effect of Anakinra on Insulin Secretion
The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction

Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.

Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
  • Glucose Intolerance
  • Impaired Insulin Secretion
  • Diabetes Mellitus Type 2
Drug: Anakinra
150 mg sc once daily during four weeks
Other Names:
  • Kineret
  • Interleukin1-receptor antagonist
  • Experimental: Anakinra
    Anakinra 150 mg/day during four weeks
    Intervention: Drug: Anakinra
  • Placebo Comparator: Placebo
    Placebo during four weeks
    Intervention: Drug: Anakinra
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2012
March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%
  • BMI >25 kg/m2
  • Age 40-70 years

Exclusion Criteria:

  • Known diabetes mellitus
  • Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
  • Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
  • Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
  • Signs of current infection (fever, C-reactive protein >30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)
  • A history of recurrent infections
  • Pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
  • Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
  • Renal disease defined as MDRD < 60 ml/min/1.73m2
  • Neutropenia < 2x 109/L
  • Inability to understand the nature and extent of the trial and the procedures required.
  • Any medical condition that might interfere with the current study protocol
  • Participation in a drug trial within 60 days prior to the first dose
Sexes Eligible for Study: All
40 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Radboud University
Radboud University
Not Provided
Principal Investigator: C.J. Tack, MD, PhD, Prof. of Diabetology Radboud University
Radboud University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP