NDLI: CCR2 antagonism in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study.

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CCR2 antagonism in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Di Prospero, N. A. Artis, E. Andrade-Gordon, P. Johnson, D. L. Vaccaro, N. Xi, L. Rothenberg, P.
Spatial Coverage	United States
Description	Country affiliation: United States Author Affiliation: Di Prospero NA ( Department of Translational Medicine, Janssen Research & Development, Raritan, NJ, USA.)
Abstract	AIMS: Macrophage recruitment through C-C motif chemokine receptor-2 (CCR2) into adipose tissue is believed to play a role in the development of insulin resistance and type 2 diabetes mellitus (T2DM). The objective of this Phase 2 proof-of-concept study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JNJ-41443532, an orally bioavailable CCR2 antagonist, in patients with T2DM. METHODS: This was a 4-week, double-blind, placebo-controlled, randomized, multicenter study. A total of 89 patients were randomized to receive either 250- or 1000-mg of JNJ-41443532 twice daily, 30-mg of pioglitazone once daily (reference arm), or placebo. The primary endpoint was change from baseline in 23-h weighted mean glucose (WMG); secondary endpoints included change from baseline in fasting plasma glucose (FPG), insulin resistance (Homeostatic Model Assessment [HOMA-IR]), insulin secretion (HOMA-%B) and body weight. RESULTS: Absorption of JNJ-41443532 into the systemic circulation occurred at a median tmax of 2 h, and the mean t½ was approximately 8 h for both doses; plasma systemic exposures increased slightly more than dose-proportionally. After 4 weeks, reductions in 23-h WMG and FPG were observed in all treatment groups compared with placebo and were significantly lower for 250-mg JNJ-41443532 and pioglitazone. HOMA-IR was lower for all treatment groups, but significantly lower only for pioglitazone. Conversely, HOMA-%B was increased for all groups, but significantly increased only for 250-mg JNJ-41443532. All groups, including placebo, had decreased body weight over time. There were no clinically significant findings during routine safety assessments and the incidence of treatment-emergent adverse events was similar across all groups. CONCLUSIONS: Administration of JNJ-41443532 resulted in modest improvement in glycaemic parameters compared with placebo, and was generally well tolerated in patients with T2DM.
File Format	HTM / HTML
ISSN	14628902
Issue Number	11
Volume Number	16
e-ISSN	14631326
Journal	Diabetes, Obesity and Metabolism
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2014-11-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Metabolism Discipline Endocrinology Discipline Pharmacology Discipline Diabetology Blood Glucose Drug Effects Diabetes Mellitus, Type 2 Drug Therapy Hemoglobin A, Glycosylated Hypoglycemic Agents Pharmacokinetics Receptors, Ccr2 Antagonists & Inhibitors Thiazolidinediones Adult Azetidines Administration & Dosage Pharmacology Benzamides Body Mass Index Epidemiology Directive Counseling Double-blind Method Drug Administration Schedule Fasting Female Humans Male Middle Aged Treatment Outcome United States Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Endocrinology, Diabetes and Metabolism Internal Medicine Endocrinology

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CCR2 antagonism in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study.

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