Boston Therapeutics starts study of BTI320 on type 2 diabetics on metformin
Boston Therapeutics announces the start of a new double-blind, placebo-controlled study that will confirm the potential of the newly patented investigative material to support and possibly enhance current anti-diabetic regimen of glycemic control in subjects with type diabetes. First subject in the multicenter trial was consented on September 18. The objective of this confirmatory, proof of concept adaptive study is to assess appropriate efficacy of clinical benefit and contribute to the growing safety of BTI320.It is hypothesized that BTI320, through this simple immediate post-meal effect on blood sugar, may help stall or delay the progression of diabetes and other related complications. BTI320 is designed to reduce glycemic variabilities, as shown by indices captured through the rapidly emerging continuous glucose monitoring systems. CGMS is an innovative way to limit "finger sticking "for blood sampling, and replace it with a system that provides reliable immediate understanding of the direct effect of the food and drinks that are being consumed. The current multicenter clinical study is designed to confirm the appropriate outcome effects of BTI320 on specific postprandial glucose excursions and possibility of better control of variability in type 2 diabetics. We have employed the innovative, "Big Data" approach through the use of the Abbott Freestyle Libre Pro, which will be used to collect glycemic parameters hourly for several days and over the variable meal programs of each individual. This commercially available CGMS is factory-calibrated, and thereby eliminates subject finger prick calibration. It also assures a high degree of data integrity and reduces both the trial time to assessment and the time to expand and complete the registration trials.