The Effect of Anakinra on Insulin Secretion

Diabetes Mellitus Type 2 Clinical Trial

Official title:

The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01285232
• Other study ID #: Anakinra1
• Status: Active, not recruiting
• Phase: N/A
• First received: November 8, 2010
• Last updated: March 23, 2012
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 TNFa 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Insulin Secretion

Intervention

Drug:
• Anakinra
150 mg sc once daily during four weeks

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .		after 4 weeks of treatment with anakinra	No
Secondary	To determine the effect on anakinra on insulin sensitivity.	Oral glucose tolerance test	after 4 week treatment of anakinra	No
Secondary	Effects of anakinra on fat cell morphology and gene expression	Fatbiopsy	after 4 weeks of treatment with anakinra	No