NCT00303394

Brief Summary

Aim: To investigate the therapeutic potential of IL-1Ra in type 2 diabetes. Rationale: Since the major defect leading to a decrease in b-cell mass in type 2 diabetes is increased apoptosis, therapeutic approaches designed to arrest apoptosis could be a significant new development in its management. This approach might actually reverse the disease to a degree rather than just palliate glycemia. Based on current thinking, treatment with IL-1Ra appears as a promising approach. The prospected effect is blocking of the IL-1b-mediated glucotoxicity and thereby to prevent the decline in b-cell mass, together with a rapid restoration of b-cell function. FDA approval for IL-1Ra in the treatment of rheumatoid arthritis occurred based on a favourable tolerability profile.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started Apr 2004

Typical duration for phase_2 type-2-diabetes

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2006

Completed
Last Updated

March 5, 2007

Status Verified

March 1, 2007

First QC Date

March 14, 2006

Last Update Submit

March 2, 2007

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes, IL-1, inflammation, glucotoxicity, insulin

Outcome Measures

Primary Outcomes (1)

  • HbA1c

Secondary Outcomes (7)

  • Insulin requirement

  • Stimulated C peptide and insulin

  • Fasting plasma glucose (FPG)

  • Serum cytokine levels, CRP

  • Insulin secretion and Insulin-sensitivity index derived from an OGTT with insulin and glucose measurements.

  • +2 more secondary outcomes

Interventions

IL-1RaDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>20
  • Diabetes mellitus Type 2 (American Diabetes Association criteria) of at least 3 months duration
  • HbA1c \>7.5%
  • Body-mass index (BMI) \> 27

You may not qualify if:

  • C-peptide \< 400pmol/l (basal )
  • Established anti-inflammatory therapy (includiung cortisone, NSAID, Cox-2-inhibitor). Low dose aspirin (£ 100mg) will be tolerated.
  • CRP \>30 mg/dl, fever, current treatment with antibiotics, or chronic granulomatous infections (e.g. tuberculosis) in the history or on a screening chest X-ray.
  • Neutropenia or anemia (leucocyte count \< 2.0x109 /l, hemoglobin \<11g/dl for ma les or \<10g/dl for females)
  • Severe liver or renal disease ( AST or ALT\>3 times the upper limit of normal laboratory range, serum creatinine \>130mM)
  • Ongoing malignant neoplasm
  • Use of any investigational drug within 30 days of enrollment into the study or within 5 half-lives of the investigational drug (whichever is longer)
  • Immunosuppressive treatment or immunodeficient diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Steno Diabetes Center

Gentofte Municipality, Copenhagen, 2280, Denmark

Location

University Hospital of Zurich, Division of Endocrinology and Diabetes

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

  • de Baat A, Trinh B, Ellingsgaard H, Donath MY. Physiological role of cytokines in the regulation of mammalian metabolism. Trends Immunol. 2023 Aug;44(8):613-627. doi: 10.1016/j.it.2023.06.002. Epub 2023 Jul 7.

    PMID: 37423882DERIVED

  • Larsen CM, Faulenbach M, Vaag A, Volund A, Ehses JA, Seifert B, Mandrup-Poulsen T, Donath MY. Interleukin-1-receptor antagonist in type 2 diabetes mellitus. N Engl J Med. 2007 Apr 12;356(15):1517-26. doi: 10.1056/NEJMoa065213.

    PMID: 17429083DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2InflammationInsulin Resistance

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Marc Y Donath, MD

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 16, 2006

Study Start

April 1, 2004

Study Completion

March 1, 2006

Last Updated

March 5, 2007

Record last verified: 2007-03

Locations

CH(1)DK(1)