The Effect of Anakinra on Insulin Secretion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01285232
First received: November 8, 2010
Last updated: March 23, 2012
Last verified: September 2010
  Purpose

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.


Condition Intervention
Glucose Intolerance
Impaired Insulin Secretion
Diabetes Mellitus Type 2
Drug: Anakinra

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps . [ Time Frame: after 4 weeks of treatment with anakinra ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effect on anakinra on insulin sensitivity. [ Time Frame: after 4 week treatment of anakinra ] [ Designated as safety issue: No ]
    Oral glucose tolerance test

  • Effects of anakinra on fat cell morphology and gene expression [ Time Frame: after 4 weeks of treatment with anakinra ] [ Designated as safety issue: No ]
    Fatbiopsy


Estimated Enrollment: 16
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anakinra
Anakinra 150 mg/day during four weeks
Drug: Anakinra
150 mg sc once daily during four weeks
Other Names:
  • Kineret
  • Interleukin1-receptor antagonist
Placebo Comparator: Placebo
Placebo during four weeks
Drug: Anakinra
150 mg sc once daily during four weeks
Other Names:
  • Kineret
  • Interleukin1-receptor antagonist

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285232

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: C.J. Tack, MD, PhD, Prof. of Diabetology Radboud University
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01285232     History of Changes
Other Study ID Numbers: Anakinra1
Study First Received: November 8, 2010
Last Updated: March 23, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014