Remogliflozin etabonate: Additional Phase IIb data

Additional data from a double-blind, dose-ranging, placebo- and pioglitazone-controlled, international Phase IIb trial in 336 treatment-naive patients with Type II diabetes showed that twice-daily 50, 100, 250, 500 and 1,000 mg remogliflozin etabonate improved insulin sensitivity by 6.3-32.6% from baseline to week 12 vs. 3.4% for placebo and improved beta cell function by 23.1-42.7% vs. a reduction of 2.5% for placebo. Additionally, a post hoc analysis of patients with elevated alanine aminotransferase (ALT) levels at baseline showed that remogliflozin etabonate significantly reduced mean ALT levels from baseline to week 12 by 32-42% vs. 6.7% for placebo (p<0.049). Data were presented at the European Association for the Study of the Liver meeting in Vienna. Previously reported data from this and a second Phase IIb trial showed that all doses of once- and twice-daily remogliflozin etabonate met the primary endpoint of reducing HbA1c from baseline to week 12 vs. placebo (see BioCentury, April 21, 2014). ...