|By PR Newswire||
|June 22, 2013 11:00 AM EDT||
SAN DIEGO, June 22, 2013 /PRNewswire/ -- Elcelyx Therapeutics announced today that clinical study results confirm that the primary site of action of Type 2 diabetes medicine metformin is in the lower bowel rather than in the circulation. The study revealed that contrary to popular belief, greater exposure in the plasma of metformin does not improve efficacy of the most prescribed diabetes medicine in the world. Elcelyx's Phase 2a study demonstrated this by comparing the glucose-lowering effects of NewMet™, the company's proprietary delayed-release formulation of metformin, to generic metformin in patients with Type 2 diabetes.
NewMet is formulated to target the entire dose to the lower bowel and limit absorption into the blood. In the crossover study, 5-day treatment with NewMet had similar fasting and post-meal glucose reductions from baseline as 5-day treatment with generic metformin despite greater than 45% reductions in metformin plasma concentrations. In addition, NewMet had less gastrointestinal (GI) side effects than generic metformin. Results of the clinical trial will be presented at ADA on Sunday by Dr. Ralph DeFronzo, Professor of Medicine and Chief of the Diabetes Division at the University of Texas Health Science Center and the Audie L. Murphy Memorial Veterans Administration Hospital in San Antonio, Texas.
The significantly lower metformin plasma concentration observed with NewMet suggests that it might be safely used by patients with moderate and severe renal impairment, a population of patients that is unable to use currently available metformin formulations due to the risk of lactic acidosis caused by too much metformin in the blood. Mark Fineman, Ph.D., Senior Vice President of Research & Development at Elcelyx will present a second poster, accepted as a late-breaker that describes 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. Secondary 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
- 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
- Date and Time: Sunday, June 23, 2013, 12:00 p.m. to 2:00 p.m. CT
- Poster #, Category: 75-LB, 01-D Clinical Therapeutics/New Technology – Oral Agents
About Elcelyx Therapeutics
Elcelyx Therapeutics develops pharmaceutical and consumer healthcare products based on its proprietary Gut Sensory Modulation (GSM) platform. Pharmaceutical product candidate NewMet™ is being developed for use by Type 2 diabetes patients who have difficulty tolerating generic metformin or are contraindicated for its use. In the consumer health area, Elcelyx is developing Lovidia™ as a dietary supplement for weight management. These product candidates are backed by rigorous science and clinical data and present near-term, blockbuster commercial opportunities. Elcelyx is based in San Diego, CA. For more information, visit www.Elcelyx.com.
SOURCE Elcelyx Therapeutics
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
Aug. 24, 2016 02:00 PM EDT Reads: 1,817
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Aug. 24, 2016 02:00 PM EDT Reads: 370
SYS-CON Events announced today that Venafi, the Immune System for the Internet™ and the leading provider of Next Generation Trust Protection, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Venafi is the Immune System for the Internet™ that protects the foundation of all cybersecurity – cryptographic keys and digital certificates – so they can’t be misused by bad guys in attacks...
Aug. 24, 2016 12:30 PM EDT Reads: 2,525
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Aug. 24, 2016 12:15 PM EDT Reads: 1,785
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 24, 2016 12:00 PM EDT Reads: 3,828
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Aug. 24, 2016 11:45 AM EDT Reads: 1,425
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aug. 24, 2016 11:45 AM EDT Reads: 3,340
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Aug. 24, 2016 11:00 AM EDT Reads: 376
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Aug. 24, 2016 11:00 AM EDT Reads: 2,077
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 24, 2016 10:48 AM EDT Reads: 332
Ixia (Nasdaq: XXIA) has announced that NoviFlow Inc.has deployed IxNetwork® to validate the company’s designs and accelerate the delivery of its proven, reliable products. Based in Montréal, NoviFlow Inc. supports network carriers, hyperscale data center operators, and enterprises seeking greater network control and flexibility, network scalability, and the capacity to handle extremely large numbers of flows, while maintaining maximum network performance. To meet these requirements, NoviFlow in...
Aug. 24, 2016 10:45 AM EDT Reads: 1,786
Enterprises have forever faced challenges surrounding the sharing of their intellectual property. Emerging cloud adoption has made it more compelling for enterprises to digitize their content, making them available over a wide variety of devices across the Internet. In his session at 19th Cloud Expo, Santosh Ahuja, Director of Architecture at Impiger Technologies, will introduce various mechanisms provided by cloud service providers today to manage and share digital content in a secure manner....
Aug. 24, 2016 10:30 AM EDT Reads: 447
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Aug. 24, 2016 10:19 AM EDT Reads: 297
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Aug. 24, 2016 10:00 AM EDT Reads: 443
In today's uber-connected, consumer-centric, cloud-enabled, insights-driven, multi-device, global world, the focus of solutions has shifted from the product that is sold to the person who is buying the product or service. Enterprises have rebranded their business around the consumers of their products. The buyer is the person and the focus is not on the offering. The person is connected through multiple devices, wearables, at home, on the road, and in multiple locations, sometimes simultaneously...
Aug. 24, 2016 09:45 AM EDT Reads: 2,243