Treatment of Patients With Type 2 Diabetes With an Interleukin-1 Antagonist
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||Phase 2 Study of IL-1Ra in Patients With Type 2 Diabetes|
- 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.
- In a subgroup of patients, insulin-sensitivity assessed by clamp techniques
- Insulin signaling- and cytokine- gene expression profiles derived from muscle and fat biopsy samples.
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||March 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303394
|Steno Diabetes Center|
|Gentofte, Copenhagen, Denmark, 2280|
|University Hospital of Zurich, Division of Endocrinology and Diabetes|
|Zurich, Switzerland, 8091|
|Study Chair:||Marc Y Donath, MD||University of Zurich|