The effect of interleukin-1 receptor antagonist on insulin secretion - Anakinra and insulin secretion

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019660-36-NL

Enrollment

Registered

2010-06-10

Start date

2010-12-07

Completion date

Unknown

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-cell dysfunction MedDRA version: 12.1 Level: LLT Classification code 10052341 Term: Impaired insulin secretion

Interventions

Trade Name: Kineret Product Name: Anakinra Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous u

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Known diabetes mellitus - Fasting plasma glucose > 7.0 mmol/L or HbA1c > 6.5% - Elevated risk for infections - Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to determine whether blocking interleukin-1 by recombinant human interleukin-1 receptor antagonist (IL-1ra) improves beta-cell function in subjects with impaired beta-cell function .;Secondary Objective: Secondary Objective(s): • To determine the effect of IL-1 blockade on insulin sensitivity following four week treatment with anakinra and placebo • To determine the effect of IL-1 blockade on fat cell morphology, fat cell insulin sensitivity and fat cell gene expression following four week treatment with anakinra and placebo. • To determine the effect of IL-1 blockade on plasma levels of inflammatory markers and adipokines following four week treatment with anakinra and placebo. ;Primary end point(s): Insulin secretion	—

Measure

Time frame

Main Objective: The primary objective is to determine whether blocking interleukin-1 by recombinant human interleukin-1 receptor antagonist (IL-1ra) improves beta-cell function in subjects with impaired beta-cell function .;Secondary Objective: Secondary Objective(s): • To determine the effect of IL-1 blockade on insulin sensitivity following four week treatment with anakinra and placebo • To determine the effect of IL-1 blockade on fat cell morphology, fat cell insulin sensitivity and fat cell gene expression following four week treatment with anakinra and placebo. • To determine the effect of IL-1 blockade on plasma levels of inflammatory markers and adipokines following four week treatment with anakinra and placebo. ;Primary end point(s): Insulin secretion

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026