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Elcelyx Therapeutics Reports Positive Data for NewMet in Type 2 Diabetes at 2013 American Diabetes Association Scientific Sessions
Date:6/22/2013

es a model designed to predict concentrations of metformin in the blood that would occur if patients with Type 2 diabetes and mild, moderate or severe renal impairment were to take NewMet. The results of the model suggest that patients with renal impairment taking effective doses of NewMet would not have an increased risk of lactic acidosis caused by accumulation of metformin in the blood. Elcelyx will be initiating a pharmacokinetic study this summer in Type 2 diabetes patients with mild, moderate and severe renal impairment to confirm the predictions of the model.

"Metformin is the preferred initial pharmacological agent for Type 2 diabetes, but in the U.S., 40% of patients with diabetes are not taking it primarily due to issues of GI tolerability or due to the contraindication of their renal impairment. Moreover, of the 60% who are taking metformin, only about 40% are able to titrate to fully effective doses due to tolerability issues," said John Buse, M.D., Professor of Medicine and Director, Diabetes Care Center, Chief, Division of Endocrinology, Executive Associate Dean for Clinical Research at University of North Carolina School of Medicine, Chapel Hill, North Carolina. "The NewMet results to date hold the promise of addressing all these patient segments. This is very encouraging news for physicians who would like to be in compliance with ADA treatment guidelines and have their patients benefit from metformin therapy." Dr. Buse was an advisor on the Phase 2a NewMet clinical study.

To confirm results observed to date, a multicenter, double-blind dose-finding Phase 2b trial evaluating NewMet once-daily doses of 1,000, 800 and 600 milligrams compared to placebo is underway.  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 four weeks of treatment. Seconda
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