Treatment of Patients With Type 2 Diabetes With an Interleukin-1 Antagonist
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|ClinicalTrials.gov Identifier: NCT00303394|
Recruitment Status : Completed
First Posted : March 16, 2006
Last Update Posted : March 5, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: IL-1Ra||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Phase 2 Study of IL-1Ra in Patients With Type 2 Diabetes|
|Study Start Date :||April 2004|
|Estimated Study Completion Date :||March 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|