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ARTICLE | Clinical News

LX4211 tablet: Phase II data

April 21, 2014 7:00 AM UTC

Top-line data from a double-blind, U.S. Phase II trial in 33 Type I diabetics inadequately controlled on either an insulin pump or multiple insulin injection therapy showed that once-daily 400 mg oral LX4211 given before breakfast for 28 days met the primary endpoint of reducing total daily mealtime bolus insulin dose vs. placebo. Specifically, LX4211 reduced total daily mealtime bolus insulin dose from baseline to day 28 by 32% compared to a 6% reduction for placebo (p=0.007). LX4211 also met the secondary endpoints of reducing mean HbA1c from baseline to day 28 (0.55% vs. 0.06%, p=0.002), increasing time spent in a glucose range of 70-180 mg/dL (11.8% vs. a reduction of 1.9%, p=0.003), reducing time spent in hyperglycemic range (10.7% vs. an increase of 4.6%, p=0.002) and reducing body weight (1.72 kg vs. an increase of 0.5 kg, p=0.005) vs. placebo. LX4211 was well tolerated with no discontinuations due to adverse events and no increase in hypoglycemia reported. ...