- A Study to Evaluate the Effect of BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycemia in High Risk Chinese Subjects with Pre-Diabetes
LAWRENCE, Mass., June 19, 2017 (GLOBE NEWSWIRE) -- Mr. Carl Rausch, CEO of Boston Therapeutics, Inc. (OTCQB:BTHE) and its Asian partner Advance Pharmaceutical Company Limited, Hong Kong had data presented from the proof of concept trial (Protocol Code: SG01) conducted by the Chinese University of Hong Kong (CUHK). Presentation is made this June 2017 in a presentation at the ADA’s 77th scientific sessions (Abstract: Hyperglycemia in High-Risk Chinese Subjects with Prediabetes) in San Diego, California (June 9-13). A copy of the abstract is printed in the Scientific Sessions Abstract Book (June 2017), supplement to the journal Diabetes. This 16-week, phase 2, double blind, randomized, placebo-controlled, POC study in Chinese subjects with pre-diabetes examined for the glucose-management effects of BTI320 and the demonstration of the safety as well as the positive drug effect of BTI320 on postprandial hyperglycemia in the selected population. Both the clinical report and manuscript are under preparation for submission to competent authorities for review with the goal of supporting the on-going clinical development of the compound. Clinical findings of the trial have been posted on Clinicaltrials.gov (NCT02358668) as of Jan 2017.
Type 2 diabetes is a multi-factorial disease and the biggest challenge in maintaining healthy blood sugar level is the management of post-prandial (after meal) sugar spikes. Targeting post-meal plasma glucose is an important strategy for achieving optimal glycemic control in the long run. Given the clinical significance on the development and progression of diabetes and related metabolic syndromes, special focus for intervention including personalized diets to control postprandial glucose excursion (PPGE) and glycemic variability for modification in subsequent metabolic consequences were considered in this POC study in high risk pre-diabetic Chinese subjects. Results show that BTI320 significantly reduced postprandial hyperglycemia and glycemic variability, as measured by CGMS in subjects at high risk for diabetes. No significant differences were detected (normal range fructosamine) in subjects treated with BTI320 and placebo, nonetheless, significant attenuation of postprandial hyperglycemia and multiple CGM glycemic variability parameters were observed in subjects receiving BTI320 (4g) compared with placebo. It is also noted that treatment with 4g BTI320 significantly reduced post-prandial glucose AUC at 1, 2 and 3 hours post meal and modestly reduced body weight. We believe that this may be the optimal dose in terms of delaying glucose absorption in the GI tract.
Overall, BTI320 was well tolerated and these positive findings suggest that BTI320 works by predominately suppressing postprandial glucose excursion, slowing down the rate of glucose excursion, as well as reducing the absolute amount absorbed, thereby preventing hyperglycemia without the risk of hypoglycemia. As such, BTI320, if approved, may potentially slow down and possibly delay diabetes progression. Given the ease of administration and high levels of tolerance, BTI320 has the potential to be used as an adjunct to lifestyle modification for diabetes prevention.
SugarDown®
The Company also developed and markets SugarDown®, a sugar blocker dietary food supplement designed to support glycemic health. More information is available at www.bostonti.com. SugarDown® in its present formulation is a natural sugar blocker dietary supplement product made entirely from a non-digestible sugar molecule that can help people maintain healthier weight levels and is the first chewable tablet of its kind. In a previous study, SugarDown® demonstrated significant reduction of glucose and insulin Area Under the Curve (AUC) when taken with Jasmine rice, a food with a glycemic index of about 90 compared to glucose, which is 100. Sugary soft drinks that also have high glycemic index, include sucrose and maltose which is also found in beer. More information can be found on www.sugardown.com
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Lawrence MA, (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, a non-systemic chewable therapeutic compound designed to reduce HbA1C.
Forward Looking Statement
This press release includes forward-looking statements. These statements may be identified by words such as “feel,” “believes,” “expects,” “estimates,” “projects,” “intends,” “should,” “is to be,” or the negative of such terms, or other comparable terminology. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ materially from the forward-looking statements contained herein. Factors that could cause actual results to differ materially include, but are not limited to: our limited operations and need to expand in the near future; risks associated with obtaining regulatory approval of our products; the ability to protect our intellectual property; the potential lack of market acceptance of our products; potential competition; our inability to retain key members of our management team; our inability to raise additional capital to fund our operations and business plan; our ability to continue as a going concern; our liquidity and other risks and uncertainties and other factors discussed from time to time in our filings with the Securities and Exchange Commission (“SEC”), including our annual report on Form 10-K filed with the SEC. Boston Therapeutics expressly disclaims any obligation to publicly update any forward-looking statements contained herein, whether as a result of new information, future events or otherwise, except as required by law.
Contact: Boston Therapeutics, Inc. Carl W. Rausch CEO Phone: 603-935-9799 Email: carl.rausch@bostonti.com www.bostonti.com
