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Fly News Breaks for December 21, 2016
LXRX
Dec 21, 2016 | 06:56 EDT
Lexicon Pharmaceuticals' pivotal inTandem2 Phase 3 clinical trial of sotagliflozin met its primary endpoint, showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on optimized insulin therapy. Top-line results from the Phase 3 study showed that patients treated with sotagliflozin had mean A1C reductions from baseline of 0.39% on 200mg once daily sotagliflozin dose and 0.37% on 400mg once daily sotagliflozin dose as compared to a reduction of 0.03% on placebo after 24 weeks of treatment, meeting the study's primary endpoint. This statistically significant and clinically meaningful improvement in A1C for both doses of sotagliflozin was achieved with a favorable overall safety profile in the study, including rates of severe hypoglycemia similar to placebo and low overall rates of diabetic ketoacidosis.
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