drugset / Trial / NCT00303394

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

NCT00303394

RandomizedFactorialDouble-blindTreatment

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.

Timeline

Start
2004-04
Primary completion
Completion
2006-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 100 mg Subcutaneous