Treatment of Patients With Type 2 Diabetes With an Interleukin-1 Antagonist

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborators: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Age >20

• Diabetes mellitus Type 2 (American Diabetes Association criteria) of at least 3 months duration

• HbA1c >7.5%

• Body-mass index (BMI) > 27

Exclusion Criteria:

• Positive GAD 65 or IA-2 antibodies at inclusion.

• HbA1c >12%, polyuria and thirst (exclusion of severely decompensated patients)

• 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)

• Pregnancy or breast-feeding. When appropriate (fertile women),anticonception for at last 3 month prior inclusion will be required.

• 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.