The Effect of Anakinra on Insulin Secretion

Not Applicable

• Conditions: Impaired Insulin Secretion; Glucose Intolerance; Diabetes Mellitus Type 2
• Interventions: Drug: Anakinra

• Registration Number: NCT01285232
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-11-08
• Study Start: 2011-01
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2012-03
• Last Update Submitted: 2012-03-23
• Last Update Posted: 2012-03-26
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anakinra	Anakinra	Anakinra 150 mg/day during four weeks
Placebo	Anakinra	Placebo during four weeks

Primary Outcome Measures

Name	Time	Method
To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .	after 4 weeks of treatment with anakinra

Secondary Outcome Measures

Name	Time	Method
To determine the effect on anakinra on insulin sensitivity.	after 4 week treatment of anakinra	Oral glucose tolerance test
Effects of anakinra on fat cell morphology and gene expression	after 4 weeks of treatment with anakinra	Fatbiopsy

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands