Effect of Interleukin-1 receptor antagonist on insulin sensitivity in subjects with type 1 diabetes mellitus. - Effect of IL-1RA on insulin sensitivity

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023479-24-NL

Enrollment

Registered

2010-11-08

Start date

2011-02-03

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

diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Interventions

Trade Name: Kineret Pharmaceutical Form: Solution for injection INN or Proposed INN: ANAKINRA CAS Number: 143090-92-0 Other descriptive name: kineret Concentration unit: mg/ml milligram(s)/millilitre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 1 diabetes with absence of residual Beta-cell function Age 18-65 yrs Body mass index of > 25 kg/m2 Insulin requirement > 0.5 U/kg bodyweight HbA1c>7.5%, stable glycemic control 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Inability to give informed consent Presence of any medical condition that might interfere with the current study protocol. Immunodeficiency or immunosuppressive treatment (including TNFa blocking agents and corticosteroids) Anti-inflammatory drugs (including nonsteroidal anti-inflammatory drugs, 100 mg or less of aspirin per day is allowed) Signs of current infection (fever, C-reactive protein (CRP) > 30 mmol/l, treatment with antibiotics, previous or current diagnosis of tuberculosis. A history of recurrent infections Pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women) Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range) Renal disease (creatinine > 130 µmol/l Neutropenia < 2 x 109/l

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to determine whether blockade of IL-1 signalling by Interleukin-1 receptor antagonist improves insulin sensitivity. ;Secondary Objective: Secondary objectives are to determine wheter blockade of IL-1 signalling by Interleukin-1 receptor antagonist improves adipocyte insulin sensitivity and adipose tissue morphology and changes circulating inflammatory factors, adipokine levels and lipid profile.;Primary end point(s): whole body insulin sensitivity	—

Measure

Time frame

Main Objective: The primary objective of the trial is to determine whether blockade of IL-1 signalling by Interleukin-1 receptor antagonist improves insulin sensitivity. ;Secondary Objective: Secondary objectives are to determine wheter blockade of IL-1 signalling by Interleukin-1 receptor antagonist improves adipocyte insulin sensitivity and adipose tissue morphology and changes circulating inflammatory factors, adipokine levels and lipid profile.;Primary end point(s): whole body insulin sensitivity

—

Countries

Netherlands

Outcome results

None listed

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