The Effect of Anakinra on Insulin Secretion

NCT ID: NCT01285232

Last Updated: 2012-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Glucose Intolerance; Impaired Insulin Secretion; Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: TRIPLE

Study Groups

Anakinra

Anakinra 150 mg/day during four weeks

Group Type: EXPERIMENTAL

Anakinra

Intervention Type: DRUG

150 mg sc once daily during four weeks

Placebo

Placebo during four weeks

Group Type: PLACEBO_COMPARATOR

Anakinra

Intervention Type: DRUG

150 mg sc once daily during four weeks

Interventions

Anakinra

150 mg sc once daily during four weeks

Intervention Type: DRUG

Other Intervention Names

Kineret; Interleukin1-receptor antagonist

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C.J. Tack, MD, PhD, Prof. of Diabetology

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

Anakinra1

Identifier Type: -

Identifier Source: org_study_id