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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

ry endpoints through 12 weeks include changes in fasting plasma glucose, hemoglobin A1c, body weight and measures of safety and tolerability. The study is fully enrolled with 240 patients with Type 2 diabetes.

Phase 2a Study Details
The randomized, double-blind, three-way crossover study compared the pharmacokinetics and pharmacodynamics of NewMet to generic metformin in patients with Type 2 diabetes. Twenty-four patients were randomized to receive twice-daily oral dosing of metformin HCl immediate release (1,000 mg), low dose NewMet (500 mg), and high dose NewMet (1,000 mg) for five days each separated by a one week washout. All treatments demonstrated similar reductions from baseline values in fasting plasma glucose (16-22 mg/dL, p<0.01 for all) and postprandial glucose (8%-12%, p<0.001 for all) despite a 45%-57% reduction in circulating metformin in the high and low dose NewMet arms, respectively. Gut hormones (GLP-1 and PYY) were increased similarly by more than 50% across all treatments. No safety concerns were noted for either NewMet or metformin.

Elcelyx Therapeutics' Posters at ADA: Links to Abstracts

Dissociation between metformin plasma exposure and its glucose-lowering effect: A novel gut-mediated mechanism of action

  • Date and Time: Sunday, June 23, 2013, 12:00 p.m. to 2:00 p.m. CT
  • Poster #, Category:  1087-P, 01-D Clinical Therapeutics/New Technology – Oral Agents

Delayed-release metformin may be suitable for use in diabetes patients
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SOURCE Elcelyx Therapeutics
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