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Anti-glycation and anti-albuminuric effects of GLY-230 in human diabetes.

Author(s): Kennedy L, Solano MP, Meneghini L, Lo M, Cohen MP

Affiliation(s): University of Florida, Gainesville, FL, USA.

Publication date & source: 2010, Am J Nephrol., 31(2):110-6. Epub 2009 Nov 17.

Publication type: Randomized Controlled Trial

BACKGROUND/AIMS: Inhibiting nonenzymatic glycation with GLY-230 lowers glycated albumin without affecting hyperglycemia and ameliorates renal dysfunction in the db/db mouse, but the effects of this compound in man have not been assessed. We report results from the first clinical trial in patients with diabetes of this new glycation inhibitor. METHODS: 21 diabetic men were randomly assigned to receive a total dose of 250, 500 or 750 mg of GLY-230 or placebo (1:1:1:1.2 ratio) daily for 14 days to evaluate safety and the effect of drug on plasma concentrations of glycated albumin and on urinary albumin. RESULTS: GLY-230 dose-responsively decreased glycated albumin in all participants, in whom HbA1c did not change. Among participants exhibiting microalbuminuria at baseline, mean albumin excretion significantly decreased in patients receiving GLY-230 (microg albumin/mg creatinine = 61.4 +/- 15.8 and 29.8 +/- 10.4 at baseline and completion, respectively; p = 0.001), but not placebo. There were no serious adverse events or laboratory abnormalities, and all safety parameters remained within normal limits. CONCLUSIONS: This first-in-diabetic man study indicates that GLY-230 lowers glycated albumin and that this decrease is associated with a reduction in urine albumin excretion in patients with preexisting microalbuminuria. These data encourage further evaluation of GLY-230 in diabetic renal dysfunction. Copyright (c) 2009 S. Karger AG, Basel.

Page last updated: 2010-10-05

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