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Lexicon Pharmaceuticals Announces Phase 3 Clinical Trial Results
Sep. 09, 2016 04:28AM PST
Life Science Investing NewsLexicon Pharmaceuticals announced today that the pivotal in Tandem1 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 a background of optimized insulin.
THE WOODLANDS, Texas, Sept. 9, 2016 /PRNewswire/ — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that the pivotal in Tandem1 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 a background of optimized insulin.
According to the press release:
Top-line results from the Phase 3 study showed that patients treated with sotagliflozin had a mean A1C reduction from baseline of 0.43% on 200mg once daily sotagliflozin dose (p<0.001) and a reduction of 0.49% on 400mg once daily sotagliflozin dose (p<0.001) as compared to a reduction of 0.08% 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 without an increase in severe hypoglycemia, one of the most prevalent serious health challenges in type 1 diabetes, which was seen less frequently in both treatment arms than placebo.