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ISSN: 2155-6156

Journal of Diabetes & Metabolism
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Research Article

Orally-Administered Chemokine Receptor CCR2 Antagonist CCX140-B in Type 2 Diabetes: A Pilot Double-Blind, Randomized Clinical Trial

Markolf Hanefeld1, Ernest Schell2, Ioanna Gouni-Berthold3, Martin Melichar4, Ivana Vesela5, Dan Johnson6, Shichang Miao6, Tim J Sullivan6, Juan C Jaen6, Thomas J Schall6, Pirow Bekker6* and The CCX140-B Diabetes Study Group7

1Center for Clinical Studies in Endocrinology and Metabolic Disorders, Dresden, Germany

2Luedwigstr, Nuremberg, Germany

3Center of Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany

4Internal Medicine Outpatient Clinic, Pardubice, Czech Republic

5Internal Medicine and Diabetes Outpatient Clinic, Unicov, Czech Republic

6ChemoCentryx Inc, Mountain View, CA, USA

7See Appendix for complete list of study investigators

*Corresponding Author:
Pirow Bekker
ChemoCentryx Inc, 850 Maude Avenue
Mountain View, CA 94043, USA
Tel: 650-210-2924
Fax: 650-210-2910
E-mail: [email protected]

Received date: October 03, 2012; Accepted date: October 27, 2012; Published date: November 02, 2012

Citation: Hanefeld M, Schell E, Gouni-Berthold I, Melichar M, Vesela I, et al. (2012) Orally-Administered Chemokine Receptor CCR2 Antagonist CCX140-B in Type 2 Diabetes: A Pilot Double-Blind, Randomized Clinical Trial. J Diabetes Metab 3:225. doi:10.4172/2155-6156.1000225

Copyright: © 2012 Hanefeld M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



Abstract

Study background: Inflammatory macrophages expressing the C-C chemokine receptor 2 (CCR2) accumulate in adipose tissue and contribute to insulin resistance. CCX140-B is an orally-administered antagonist of CCR2 expressed on monocytes and macrophages and blocks infiltration of these cells into adipose tissue. A pilot Phase 2 clinical trial was conducted in patients with type 2 diabetes with the primary objective to evaluate the safety and tolerability of CCX140-B. Key secondary objectives included assessment of glycemic parameters, fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c).

Methods: This is a randomized, double-blind, clinical trial of CCX140-B in 159 subjects with type 2 diabetes on stable metformin for at least 8 weeks prior to study entry. HbA1c was 6.5 to 10% and FPG 135 to 270 mg/dL at study entry. Randomized subjects received double-blind placebo (N=32), 5 mg CCX140-B (N=63), 10 mg CCX140-B (N=32), or pioglitazone 30 mg (N=32) once daily orally for 4 weeks, with a 4-week follow-up period.

Results: CCX140-B was well tolerated. No serious adverse events occurred with CCX140-B. FPG showed a CCX140-B dose-dependent decrease, with 10 mg CCX140-B showing a similar decrease to pioglitazone (leastsquares mean change at week 4 of -16.1 vs. -21.4 mg/dL, respectively). HbA1c least-squares mean changes from baseline to week 4 for the placebo, 5 mg CCX140-B, 10 mg CCX140-B, and pioglitazone groups were -0.09%, -0.09%, -0.23% (p=0.045 vs. placebo), and -0.13% (NS vs. placebo), respectively. No detrimental changes were seen in plasma monocyte chemoattractant protein-1 or blood monocyte counts with CCX140-B.

Conclusion: CCX140-B, an orally administered, specific CCR2 antagonist was found to be well tolerated and safe in this Phase 2 clinical trial and showed evidence of a beneficial effect on glycemic parameters. If confirmed, CCX140-B might be beneficial in treatment of patients with type 2 diabetes. (Clinical Trial Registry: clinicaltrials.gov identifier NCT01028963).

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