The Effect of Anakinra on Insulin Secretion

NCT01285232 | Unknown DMC

• 1 other identifier: Anakinra1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .

  after 4 weeks of treatment with anakinra

Secondary Outcomes (2)

• To determine the effect on anakinra on insulin sensitivity.

  after 4 week treatment of anakinra

• Effects of anakinra on fat cell morphology and gene expression

  after 4 weeks of treatment with anakinra

Study Arms (2)

Anakinra

EXPERIMENTAL

Anakinra 150 mg/day during four weeks

Drug: Anakinra

Placebo

PLACEBO COMPARATOR

Placebo during four weeks

Drug: Anakinra

Interventions

Anakinra DRUG

150 mg sc once daily during four weeks

Also known as: Kineret, Interleukin1-receptor antagonist

Anakinra; Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus, Type 2

Interventions

Interleukin 1 Receptor Antagonist Protein; Receptors, Interleukin-6

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Receptors, Interleukin; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

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

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: January 27, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 26, 2012

Record last verified: 2010-09

Locations

NL (1)