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Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes
Date:5/20/2013

by targeting the hormone-producing enteroendocrine cells in the lower gut, NewMet may have better tolerability with the preserved efficacy of metformin at a lower dose. This would make NewMet ideal for the millions of Type 2 diabetes patients who have difficulty tolerating metformin or are unable to take the medication due to contraindications. I am eager to see the results of the additional planned clinical studies of NewMet to further understand this attractive profile."

Dr. DeFronzo is a world-renowned clinician, teacher and investigator who led the trials that supported the U.S. Food and Drug Administration approval of metformin in 1994. He and fellow investigators will be presenting the Elcelyx-sponsored NewMet Phase 2a trial results at the 2013 American Diabetes Association Scientific Sessions in June.

This randomized, double-blind, dose-finding Phase 2b trial is evaluating NewMet once-daily doses of 1,000, 800 and 600 milligrams compared to placebo. There are also two comparator arms with generic extended-release metformin dosed once-daily at 1,000 and 2,000 milligrams. The primary endpoint of the study is fasting plasma glucose at 4 weeks of treatment. Secondary endpoints through 12 weeks include changes in fasting plasma glucose, hemoglobin A1c, weight and measures of safety and tolerability. 

"Our research has been eye opening for physicians and endocrinologists who appreciate the clinical benefits of metformin such as glucose control and weight loss but are frustrated by its gastrointestinal side effects, need for titration and exclusion of patients with moderate and severe impaired kidney function. Type 2 diabetes patients who have difficulty tolerating generic metformin either come off of it completely or drop down to a less than maximally effective dose," explained Alain Baron , M.D., President and Chief Executive Officer of Elcelyx Therapeutics. "The goal of this study is to demonstrate that N
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SOURCE Elcelyx Therapeutics
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