Overview

This trial is active, not recruiting.

Conditions glucose intolerance, impaired insulin secretion, diabetes mellitus type 2
Treatment anakinra
Sponsor Radboud University
Start date January 2011
End date March 2012
Trial size 16 participants
Trial identifier NCT01285232, Anakinra1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Arm
(Experimental)
Anakinra 150 mg/day during four weeks
anakinra Kineret
150 mg sc once daily during four weeks
(Placebo Comparator)
Placebo during four weeks
anakinra Kineret
150 mg sc once daily during four weeks

Primary Outcomes

Measure
To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .
time frame: after 4 weeks of treatment with anakinra

Secondary Outcomes

Measure
To determine the effect on anakinra on insulin sensitivity.
time frame: after 4 week treatment of anakinra
Effects of anakinra on fat cell morphology and gene expression
time frame: after 4 weeks of treatment with anakinra

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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

Additional Information

Official title The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction
Principal investigator C.J. Tack, MD, PhD, Prof. of Diabetology
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Radboud University.