Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303394
Status:
COMPLETED
Last Update Posted:
2007-03-05
First Post:
2006-03-14
Brief Title:
Treatment of Patients With Type 2 Diabetes With an Interleukin-1 Antagonist
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Phase 2 Study of IL-1Ra in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Methodology This will be a two-centre University Hospital Zurich Switzerland and Steno Diabetes Center Gentofte Denmark study 72 patients will be randomised according to a double-blind placebo-controlled protocol in which half of the patients are treated with IL-1Ra the other half with saline The treatment period will last 13 weeks This time-period should be sufficient for reversal of functional glucotoxicity and feasible in terms of patient compliance Whether 13 weeks of treatment will be sufficient to make significant changes in b-cell mass in unpredictable However blocking b-cell apoptosis while new islet formation and b-cell replication are normal may initiate enlargement of b-cell mass which may progress beyond the treatment period Patient evaluation will be performed at start and after 4 13 26 39 and 52 weeks Following 13 weeks patients with a fasting plasma glucose levels 8 mM or with a glycosylated hemoglobin level HbA1c 8 will be treated with insulin Insulin treatment will not be initiated earlier to avoid interference with possible effects of insulin on primary outcome in the period where the largest effect of IL-1Ra are expected To assess effects of IL-1Ra on insulin sensitivity a subset of 40 patients 20 IL-1Ra- and 20 placebo-treated will undergo an euglycemic-hyperinsulinemic clamp as well as a muscle and fat biopsy at start and after the end of treatment 13 weeks The Ethics Committee of both centres have already approved the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None