Study to evaluate the efficacy and safety of BTI320 in type 2 diabetes patients on metformin and/or sulfonylureas
LAWRENCE, Mass., Aug. 22, 2019 (GLOBE NEWSWIRE) -- Boston Therapeutics (OTCQB:BTHE) is again pleased to announce full enrollment of the BTI320 Ph 2 double-blind, placebo-controlled, multicenter trial. With the recent inclusion of Miami Dade Medical Research Institute in June and IOWA Diabetes in Feb, recruitment of patients reached full enrollment on Aug 1, 2019(n=65). The study will be used to confirm the efficacy parameters as well as to contribute to safety of the investigational material. The attenuation of post-prandial immediate rise in blood glucose in T2DM patients currently on metformin and/or sulfonylureas, a key determinant in blood sugar management in everyone both diabetic and non-diabetic, as measured by the Continuous Glucose Monitor (CGM) Abbott Freestyle Libre Pro, the patented, investigational compound demonstrated in previous studies the effect on postprandial glucose reduction. We believe that when approved, BTI320 will have the potential to reduce the risk of diabetes complications, such as cardiovascular disease, retinopathy, nephropathy and neuropathy, commonly associated with persistent elevation in blood glucose levels without the common risks of hypoglycemic events.
Our public announcements have been limited due to the conservative financial management structure and our progression through the support of our Asia licensee, under BTI’s guidance. This has been recognized through support funding of trials and limited operations until a sustainable revenue is available from the region. Also our collaboration opportunity with Prof. Juliana CN Chan, (Chinese University Hong Kong) the receiver of the ADA’s 2019 Harold Rifkin Award for distinguished international service in the cause of diabetes, are being planned as a continuation of the POC study on BTI320’s efficacy and safety in Chinese with prediabetes, that was previously conducted in 2016 at the CUHK Prince of Wales Hospital.
Boston Therapeutics’ CEO, Carl W. Rausch has focused on the Asia support of the US trial to attach significance of the study for all individuals and especially Asia and India where prediabetes is taking a toll on the healthcare systems. He noted, “Processed foods increase immediate blood sugar elevations that persist too long. We slowly lose the ability to cope with this “rush” of sugar over time, and the ability of the pancreas to secrete sufficient and responsive insulin to bring blood sugar down in response to a meal (the “first response”) is lost. Diets high in added free sugar and other processed carbohydrates (fast foods) will disrupt normal glucose metabolism and one needs to monitor glucose levels in a continuous manner to better design treatment regimen for metabolic disease and the rapidly growing prediabetic conditions.”
CGM technology allows real-time monitoring of glucose excursions, taking into account the variabilities in diets and health status between individuals. We believe that Patients and individuals will be able to take control of “compliant dosing”, which plays an important role metabolic disorders and in the avoidance of hypoglycemia, one of the most common serious adverse effects of blood sugar lowering medications used to manage diabetes. These hypoglycemic events can cause both immediate and long-term harm to patients. Data collected in this study will be used to further elucidate the effectiveness of BTI320 as an adjunct tool for glycemic index support in changing the treatment of prediabetes, diabetes and related complications to eventually reverse.
NEW: Aug 1, 2019, BTI received a continuation in part of the patent 'Composition of purified double mannans for dietary supplements and method of use thereof composition' (Rausch et al, US 20179/0230969 A1)
About Boston Therapeutics, Inc. www.bostonti.com
Boston Therapeutics, headquartered in Lawrence, MA (OTCQB:BTHE) is an innovator in design, development and commercialization of compounds to treat diabetes and metabolic diseases related complications.
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