Document Detail


Effect of the urotensin-II receptor antagonist palosuran on secretion of and sensitivity to insulin in patients with Type 2 diabetes mellitus.
MedLine Citation:
PMID:  19843053     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: To investigate the effects of palosuran, a nonpeptidic, potent and selective antagonist of the urotensin-II receptor, on insulin and glucose regulation in 20 diet-treated patients with Type 2 diabetes mellitus in a double-blind, placebo-controlled, randomized, crossover, proof-of-concept study. METHODS: After 4 weeks' oral treatment with 125 mg palosuran or placebo b.i.d.,effects on insulin secretion and sensitivity and blood glucose levels were assessed by means of a hyperglycaemic glucose clamp, meal tolerance test, homeostasis model assessment-insulin resistance score, and daily self-monitoring of blood glucose. Plasma concentrations of palosuran were determined for 12 h on the last day of intake. RESULTS: Palosuran did not affect second-phase insulin response (primary end-point) during the hyperglycaemic glucose clamp in comparison with placebo [paired difference of -1.8 microU ml(-1), 95% confidence interval (CI) -7.8, 4.2]. Likewise, no effects of palosuran were detected on the first-phase insulin response, or on insulin secretion and blood glucose levels during the meal tolerance test or on homeostasis model assessment-insulin resistance score. No clinically significant effects on daily blood glucose profiles were observed during the study. Geometric mean C(max) and AUC(tau) (95% CI) and median t(max) (range) in this patient population were 180 ng ml(-1) (125, 260), 581 ng.h ml(-1) (422, 800) and 3.0 h (0.67, 4.3), respectively. CONCLUSIONS: The results of this study indicate that antagonism of the urotensin-II system does not influence insulin secretion or sensitivity or daily blood glucose levels in diet-treated patients with Type 2 diabetes.
Authors:
Patricia N Sidharta; Klaus Rave; Lutz Heinemann; Eleonora Chiossi; Stephan Krähenbühl; Jasper Dingemanse
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  68     ISSN:  1365-2125     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-10-21     Completed Date:  2010-07-30     Revised Date:  2010-10-04    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  502-10     Citation Subset:  IM    
Affiliation:
Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd, CH-4123 Allschwil, Switzerland. patricia.sidharta@actelion.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Blood Glucose / drug effects*,  metabolism
Diabetes Mellitus, Type 2 / blood*,  drug therapy
Double-Blind Method
Female
Glucose Clamp Technique
Glucose Tolerance Test
Humans
Insulin / blood,  secretion*
Male
Middle Aged
Quinolines / blood*,  therapeutic use
Receptors, G-Protein-Coupled / blood*
Treatment Outcome
Urea / analogs & derivatives*,  blood,  therapeutic use
Urotensins / blood*
Chemical
Reg. No./Substance:
0/1-(2-(4-benzyl-4-hydroxypiperidin-1-yl)ethyl)-3-(2-methylquinolin-4-yl)urea; 0/Blood Glucose; 0/Quinolines; 0/Receptors, G-Protein-Coupled; 0/UTS2R protein, human; 0/Urotensins; 11061-68-0/Insulin; 57-13-6/Urea

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