Effects of gevokizumab on glycemia and inflammatory markers in type 2 diabetes

Cavelti-Weder, C. and Babians-Brunner, A. and Keller, C. and Stahel, M. A. and Kurz-Levin, M. and Zayed, H. and Solinger, A. M. and Mandrup-Poulsen, T. and Dinarello, C. A. and Donath, M. Y.. (2012) Effects of gevokizumab on glycemia and inflammatory markers in type 2 diabetes. Diabetes care, Vol. 35, H. 8. pp. 1654-1662.

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Official URL: http://edoc.unibas.ch/dok/A6338608

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OBJECTIVE: Metabolic activation of the innate immune system governed by interleukin (IL)-1beta contributes to beta-cell failure in type 2 diabetes. Gevokizumab is a novel, human-engineered monoclonal anti-IL-1beta antibody. We evaluated the safety and biological activity of gevokizumab in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: In a placebo-controlled, dose-escalation study, a total of 98 patients were randomly assigned to placebo (17 subjects) or gevokizumab (81 subjects) at increasing doses and dosing schedules. The primary objective of the study was to evaluate the safety profile of gevokizumab in type 2 diabetes. The secondary objectives were to assess pharmacokinetics for different dose levels, routes of administration, and regimens and to assess biological activity. RESULTS: The study drug was well tolerated with no serious adverse events. There was one hypoglycemic event whereupon concomitant insulin treatment had to be reduced. Clearance of gevokizumab was consistent with that for a human IgG(2), with a half-life of 22 days. In the combined intermediate-dose group (single doses of 0.03 and 0.1 mg/kg), the mean placebo-corrected decrease in glycated hemoglobin was 0.11, 0.44, and 0.85% after 1, 2 (P = 0.017), and 3 (P = 0.049) months, respectively, along with enhanced C-peptide secretion, increased insulin sensitivity, and a reduction in C-reactive protein and spontaneous and inducible cytokines. CONCLUSIONS: This novel IL-1beta-neutralizing antibody improved glycemia, possibly via restored insulin production and action, and reduced inflammation in patients with type 2 diabetes. This therapeutic agent may be able to be used on a once-every-month or longer schedule.
Faculties and Departments:03 Faculty of Medicine > Departement Biomedizin > Department of Biomedicine, University Hospital Basel > Diabetes Research (Donath)
UniBasel Contributors:Donath, Marc
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:American Diabetes Association
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:10 Apr 2015 09:13
Deposited On:10 Apr 2015 09:13

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