BTI-320 is a non-systemic, non-toxic, chewable investigative candidate for prevention or delay of diabetes. Also first line for reversal of prediabetes. BTI-320 inhibits the enzymes that release glucose from complex carbohydrate in foods during digestion, reducing the amount of available glucose absorbed through the intestine. BTI-320 is a safe and effective drug compound for people with pre-diabetes and diabetes in their daily management of blood glucose levels. BTI-320 may slow the onset of Type 2 diabetes and diabetes complications such as heart disease, stroke, nephropathy, retinopathy and peripheral vascular ailments. On June 22, 2012, BTI announced that it has completed enrollment in a Phase II clinical trial to evaluate the safety and efficacy of BTI-320 when added to oral agents or insulin in patients with Type 2 diabetes at Dartmouth-Hitchcock Medical Center in Lebanon, NH. Data analysis of the Phase II clinical trial showed that there were no serious adverse events from BTI-320. 24 patients with Type 2 diabetes were included in the open label, dose escalation crossover trial. The patients were adults age 18-75 with Type 2 diabetes, on insulin or oral agents, with a body mass index of 25-45 kg/m2 and with an A1C of less than or equal to 9%.
In July 2017, a proof-of-concept study to evaluate the efficacy and safety of BTI-320 on post-prandial hyperglycemia in high risk Chinese subjects with pre-diabetes was completed in Chinese University of Hong Kong. The objective of the study was to examine the glycemic efficacy, tolerability and safety of 16 weeks' intervention with BTI-320 compared with placebo in high risk Chinese adults with pre-diabetes. Results from the study conclude that low dose BTI-320 attenuate post-prandial rise in blood glucose and reduced body weight modestly. Given the ease of administration and high levels of tolerance, BTI-320 has the potential to be used as an adjunct to lifestyle modification for diabetes prevention.