Lexicon Presents LX4211 Mechanism of Action Data at American Diabetes Association Meeting and Announces Commencement of Phase 2b Clinical Trial in Type 2 Diabetes
THE WOODLANDS, Texas, June 27, 2011 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that the company presented clinical data from a mechanistic study of LX4211, a dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), in patients with type 2 diabetes at the 71st Scientific Sessions of the American Diabetes Association (ADA) in San Diego, California. In addition, the company announced that it has commenced enrollment of patients with type 2 diabetes in its Phase 2b clinical trial of LX4211.
Data from the mechanistic study demonstrated that a single dose of LX4211 significantly increased circulating levels of GLP-1 (active and total) and PYY, important regulators of glycemic and appetite control. For more information on this program or to download a copy of the poster from the ADA meeting, please visit www.lexpharma.com.
The Phase 2b trial is a randomized, double-blind, placebo controlled study of LX4211 in approximately 285 adult patients (18-75 years) with type 2 diabetes who are not adequately controlled on metformin monotherapy. Patients will be administered LX4211 in combination with standard metformin therapy over 12 weeks. Doses will include 75 mg once daily, 200 mg once daily, 200 mg twice daily, 400 mg once daily or placebo. The primary endpoint of the study is the change from baseline in HbA1c at Week 12. Secondary endpoints will include percentage of patients achieving HbA1c < 7%, and changes in fasting plasma glucose, 3-hour glucose tolerance test, weight, blood pressure, and triglycerides. The study will be conducted at ap