Navigation Links
Elcelyx Therapeutics' NewMet for Type 2 Diabetes Meets Primary Endpoint in Phase 2b Study
Date:9/4/2013

SAN DIEGO, Sept. 4, 2013 /PRNewswire/ -- Elcelyx Therapeutics announced today that NewMet™, the delayed-release formulation of generic metformin for the treatment of patients with Type 2 diabetes, met its primary study endpoint with statistically significant reductions in fasting plasma glucose at four weeks of treatment compared to placebo. 

The results from the randomized, 240-patient, multicenter U.S. Phase 2b trial confirm previous studies that showed NewMet reduced fasting plasma glucose to a similar extent as generic metformin but at plasma exposure levels previously shown to be as much as 65% lower than comparable doses of generic metformin.

The double-blind, dose-finding trial evaluated NewMet once-daily doses of 1,000, 800 and 600 milligrams compared to placebo. There were also two comparator arms with Glucophage XR dosed once-daily at 1,000 and 2,000 milligrams. Secondary endpoints through 12 weeks include changes in fasting plasma glucose, hemoglobin A1c, body weight and measures of safety and tolerability. Twelve-week results are expected in late October.

The results at four weeks provide confirmation that the primary site of metformin activity is the lower bowel and not the circulation.  The reduced systemic absorption of NewMet indicates that it may be an appropriate treatment for Type 2 diabetes patients who have renal impairment and are contraindicated for metformin use due to the risk of lactic acidosis, a life-threatening condition that can result from metformin build-up in the blood.

About Elcelyx Therapeutics, Inc.

Elcelyx Therapeutics is developing pharmaceutical product candidate NewMet™ for use by Type 2 diabetes patients who have difficulty tolerating generic metformin or are contraindicated for its use. NewMet presents a near-term, blockbuster commercial opportunity. Elcelyx is based in San Diego, CA. For more information, visit www.Elcelyx.com.

 

 


'/>"/>
SOURCE Elcelyx Therapeutics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Elcelyx Therapeutics Reports Positive Data for NewMet in Type 2 Diabetes at 2013 American Diabetes Association Scientific Sessions
2. Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes
3. Elcelyx Therapeutics Completes $20 Million Series C Financing to Advance NewMet and Lovidia
4. Elcelyx Therapeutics Names Mark Wiggins Senior Vice President of Business Development, Ginger Graham to Board of Directors
5. Aratana Therapeutics Drives Awareness of Pet Therapeutic Opportunity During "CVC Week" in Kansas City
6. Mast Therapeutics To Present At The Rodman & Renshaw 15th Annual Healthcare Conference On September 10
7. PTC Therapeutics to Present at Upcoming Investor Conferences
8. Aratana Therapeutics to Host Pet Therapeutics Primer and Product Update Event
9. Carolus Therapeutics and The Alpha-1 Project Collaborate to Validate CT-2009 Target as Important in Human Disease
10. Echo Therapeutics Announces Management Changes
11. aTyr Pharma Awarded Two Patents from USPTO to Support Development of New Therapeutics Based on Physiocrine Biology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... , Feb. 23, 2017 Non-alcoholic ... on the various drugs being developed for ... all the drugs that are in various ... The pipeline focuses on novel pharmacologic drugs ... stem cell therapies, recombinant proteins and RNA-based ...
(Date:2/24/2017)... -- Xynomic Pharmaceuticals, Inc., an oncology drug research and ... exclusive worldwide rights to develop, manufacture and commercialize ... hematological and solid tumors. To date ... clinical trials of Abexinostat in US, EU and ... completed, demonstrating that Abexinostat is clinically active in ...
(Date:2/23/2017)... Research and Markets has announced the addition of the ... report to their offering. ... The latest research Autism Spectrum Disorder Drugs Price Analysis ... the global Autism Spectrum Disorder market. The research answers the ... drugs marketed for Autism Spectrum Disorder and their clinical attributes? How ...
Breaking Medicine Technology:
(Date:2/23/2017)... ... February 23, 2017 , ... ... 2017 partnership with The Jensie Gran Fondo of Marin. For the second year ... with Thinksport’s broad-spectrum, mineral-based sunscreen. , “We are thrilled to provide our safe, ...
(Date:2/23/2017)... ... 23, 2017 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... Miami Beach to host its Swirl: Miami Wine Tasting Event on March 28, ...
(Date:2/23/2017)... ... February 23, 2017 , ... Los Angeles-based weight loss surgeon Michael ... “Mama June: From Not to Hot,” which will begin airing on February 24, 2017. ... to millions from the 2012 reality television series, “Here Comes Honey Boo Boo.” The ...
(Date:2/23/2017)... ... February 23, 2017 , ... EBSCO ... the National Institute for Health and Care Excellence (NICE) framework. The ... National Health Service (NHS) to search, order and purchase medical and healthcare-related content ...
(Date:2/23/2017)... ... February 23, 2017 , ... Pink ... publication where generations converge and explore the world from different perspectives. By providing ... enables readers to gain understanding, increase empathy, and find greater happiness. , ...
Breaking Medicine News(10 mins):