|By Marketwired .
|May 29, 2014 07:00 AM EDT
MANCHESTER, NH -- (Marketwired) -- 05/29/14 -- Boston Therapeutics, Inc. (OTCQB: BTHE), a leading developer of compounds that address diabetes using complex carbohydrate chemistry, has initiated a Phase IIb clinical study to assess the efficacy and safety of SUGARDOWN® in 24 patients with Type 2 diabetes taking metformin. The study, SD-002, is being conducted by Accumed Research Associates in Garden City, NY under the direction of Principal Investigator Mitchell D. Efros, MD, FACS.
SUGARDOWN® is Boston Therapeutics' (BTI) currently marketed dietary supplement that is intended to support healthy blood sugar. Previous clinical studies have indicated that SUGARDOWN® can maintain healthy glucose levels even after meals when sugar tends to spike.
The five-week, randomized, double-blind Phase IIb study is designed to assess the safety and efficacy of SUGARDOWN® in two different doses versus placebo on serum glucose levels after meals in 24 subjects with Type 2 diabetes treated with metformin alone. The primary endpoint of the study is postprandial serum glucose area under the curve; secondary endpoints are peak postprandial serum glucose, time to peak postprandial serum glucose, and peak blood serum excursion at two hours from baseline.
David Platt, Ph.D., Chief Executive Officer of Boston Therapeutics, said, "We are looking forward to enrolling and conducting this new study on the safety and efficacy of SUGARDOWN®, in order to corroborate the previous clinical findings we have obtained. We expect this study will strengthen the existing body of evidence that SUGARDOWN® can play a useful role in supporting healthy blood sugar levels. Having recently signed a strategic marketing agreement for SUGARDOWN® with Benchworks SD, a leading branding and marketing agency, we look forward to having the results of this clinical study help support our marketing and sales initiatives."
Individuals with Type 2 diabetes currently taking metformin who are interested in participating in the trial should visit http://www.clinicaltrials.gov/ct2/show/NCT02135549?term=SD-002&rank=1.
About Study SD-002
Subjects will undergo a screening visit, baseline visit and three treatment visits. Subjects will all receive placebo tablets at the baseline visit, eat a standard rice meal, and then serum glucose levels will be measured in frequent intervals over four hours immediately following the meal. Subjects will be randomized to one of six treatment sequences. Subjects will take in an unknown order one week of placebo, one week of 4 g dose and one week of 8 g dose of SUGARDOWN® immediately before breakfast, lunch and dinner meals. Subjects will continue their usual metformin regimen during the trial period.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is an innovator in designing compounds using complex carbohydrate chemistry. The company's product pipeline is focused on developing and commercializing therapeutic molecules that address diabetes and inflammatory diseases, including: BTI-320 (formerly PAZ320), a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug designed initially to treat lower limb ischemia associated with diabetes. The company also produces and sells SUGARDOWN®, a non-systemic complex carbohydrate-based dietary food supplement designed to support healthy blood glucose. More information is available at www.bostonti.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "may," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of any of our future drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in any subsequent drug trial could delay obtaining meaningful results from Phase II studies and/or preparing for Phase III studies with the current cash on hand.
Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from our approved products. Plans regarding development, approval and marketing of any of our compounds, including BTI-320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. We have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional risk and other factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2013, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements, and actual results may differ materially from the results anticipated in our forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
© Boston Therapeutics, Inc. All rights reserved.
Connected devices and the Internet of Things are getting significant momentum in 2014.
In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Dec. 27, 2014 11:00 AM EST Reads: 1,977
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
Dec. 27, 2014 11:00 AM EST Reads: 2,139
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open.
The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Dec. 27, 2014 11:00 AM EST Reads: 7,160
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 27, 2014 11:00 AM EST Reads: 1,890
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA.
In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
Dec. 27, 2014 11:00 AM EST Reads: 2,068
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends:
Exposing the device to a management framework
Exposing that management framework to a business centric logic
Exposing that business layer and data to end users.
This last trend is the IoT stack, which involves a new shift in the separation of what stuff happe...
Dec. 27, 2014 10:00 AM EST Reads: 2,106
DevOps is all about agility. However, you don't want to be on a high-speed bus to nowhere. The right DevOps approach controls velocity with a tight feedback loop that not only consists of operational data but also incorporates business context. With a business context in the decision making, the right business priorities are incorporated, which results in a higher value creation.
In his session at DevOps Summit, Todd Rader, Solutions Architect at AppDynamics, discussed key monitoring techniques...
Dec. 27, 2014 10:00 AM EST Reads: 1,825
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY.
Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the ...
Dec. 27, 2014 09:00 AM EST Reads: 1,889
The 3rd International @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals.
The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago.
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to th...
Dec. 27, 2014 09:00 AM EST Reads: 2,745
"There is a natural synchronization between the business models, the IoT is there to support ,” explained Brendan O'Brien, Co-founder and Chief Architect of Aria Systems, in this SYS-CON.tv interview at the 15th International Cloud Expo®, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 27, 2014 08:45 AM EST Reads: 2,870
Fundamentally, SDN is still mostly about network plumbing. While plumbing may be useful to tinker with, what you can do with your plumbing is far more intriguing. A rigid interpretation of SDN confines it to Layers 2 and 3, and that's reasonable. But SDN opens opportunities for novel constructions in Layers 4 to 7 that solve real operational problems in data centers. "Data center," in fact, might become anachronistic - data is everywhere, constantly on the move, seemingly always overflowing. Net...
Dec. 27, 2014 08:00 AM EST Reads: 2,085
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and asse...
Dec. 27, 2014 08:00 AM EST Reads: 2,418
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now 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 large...
Dec. 27, 2014 08:00 AM EST Reads: 2,677
SYS-CON Media announced that Centrify, a provider of unified identity management across cloud, mobile and data center environments that delivers single sign-on (SSO) for users and a simplified identity infrastructure for IT, has launched an ad campaign on Cloud Computing Journal.
The ads focus on security: how an organization can successfully control privilege for all of the organization’s identities to mitigate identity-related risk without slowing down the business, and how Centrify provides ...
Dec. 27, 2014 07:00 AM EST Reads: 1,834
The Internet of Things promises to transform businesses (and lives), but navigating the business and technical path to success can be difficult to understand.
In his session at @ThingsExpo, Sean Lorenz, Technical Product Manager for Xively at LogMeIn, demonstrated how to approach creating broadly successful connected customer solutions using real world business transformation studies including New England BioLabs and more.
Dec. 27, 2014 06:45 AM EST Reads: 2,112