Ernest Schell
Germany
Research Article
Orally-Administered Chemokine Receptor CCR2 Antagonist CCX140-B in Type 2 Diabetes: A Pilot Double-Blind, Randomized Clinical Trial
Author(s): Markolf Hanefeld, Ernest Schell, Ioanna Gouni-Berthold, Martin Melichar, Ivana Vesela, Dan Johnson, Shichang Miao, Tim J Sullivan, Juan C Jaen, Thomas J Schall and Pirow BekkerMarkolf Hanefeld, Ernest Schell, Ioanna Gouni-Berthold, Martin Melichar, Ivana Vesela, Dan Johnson, Shichang Miao, Tim J Sullivan, Juan C Jaen, Thomas J Schall and Pirow Bekker
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.. View More»
