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:4/29/2016)... April 29, 2016 ... Financier Sanofi, leader mondial ... ses résultats pour le premier trimestre ... Jérôme Contamine, commente les résultats du ... perspectives pour le reste de l,année. ...
(Date:4/28/2016)... 2016 Research and Markets has ... Products Market 2016-2020" report to their offering. ... The global plastic surgery products market is expected ... period 2016-2020. , ,The growing adoption of laser in ... of the market. Lasers are used to treat a ...
(Date:4/28/2016)... , Net Sales of $1.90 billion represent ... prior year period, and an increase of 1.2% on an ... for the first quarter were $0.52 reported, a decrease of ... increase of 29.9% over the prior year period , ... for 2016 Zimmer Biomet Holdings, Inc. (NYSE and ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 29, 2016 , ... Mobility Designed is redefining mobility ... the armpits, the M+D Crutch evenly distributes body weight from the elbow to the ... when using the crutches than with other crutches. , Co-founders Max and Liliana Younger ...
(Date:4/29/2016)... ... ... is the deadliest type of skin cancer. Although only about 1 percent of skin cancer ... than 10,000 people are expected to die of melanoma this year. The risk increases with ... the most commonly diagnosed cancers in young women. A recent breakthrough in genetic studies may ...
(Date:4/29/2016)... Beverly Hills, CA (PRWEB) , ... April 29, 2016 , ... ... distributor of devices and products for the head and neck/ear, nose and throat specialty, ... Safety Device , The KOTLER NASAL AIRWAY™ is a newly patented safety ...
(Date:4/29/2016)... Jupiter, FL (PRWEB) , ... April 29, 2016 ... ... it will feature Grassland Dairy Products, Inc. in an upcoming episode, airing third ... than a century of churning cream into butter, Grassland Dairy Products, located in ...
(Date:4/29/2016)... ... April 29, 2016 , ... The infertility specialists at HRC Fertility/Orange County (HRC/OC) ... Daniel A. Potter -- are proud of the recent release of their 2014 in ... SART published the latest verified data for 375 U.S. member clinics. *Preliminary ...
Breaking Medicine News(10 mins):