The French East IV Committee of Protection of Persons (Strasbourg) and the Ministry of Health has approved the Boston Therapeutics' filing to initiate a clinical study of the efficacy and safety of Sugardown, taken together with a standard meal on post-meal sugar and insulin blood levels in patients with type II diabetes that have been treated with metformin. The company expects similar applications to be filed in the US, Hong Kong and South Korea in 2013.
"In a clinical study, we saw significant reductions of post-meal elevation of blood sugar in healthy, non-diabetic patients who were overweight," said Dr Hana Chen Walden, consulting medical director, Boston Therapeutics. "It is important for people, especially those with diabetes, to control their blood sugar levels throughout the day. We believe Sugardown may help millions of people to better manage their blood sugar."
The Company plans to enroll 24 patients with Type ll diabetes in the French study and expects to start recruiting patients in January 2013, with an estimated total duration of six months (two patients per cycle of two weeks). The primary endpoints of the dose escalating, placebo controlled study is to assess the efficacy and safety of Sugardown compared to treatment with metformin alone, to assess the effect on post-meal blood sugar levels, and to identify the average blood sugar and insulin concentrations.
Sugardown is a safe and effective dietary supplement that has been clinically proven to reduce the after meal elevation of blood sugar. Registered with the Food and Drug Administration (FDA), Sugardown is a chewable tablet that works in the stomach and intestines by blocking the enzymes that break down carbohydrates. Metformin is the most widely prescribed anti-diabetes drug in the world. In 2011, 59 million prescriptions were written for metformin in the US. In October 2012, the Company announced that the FDA had approved its petition to file an Abbreviated New Drug Application (ANDA) for a new, chewable tablet formulation of metformin.
Boston Therapeutics, a pharmaceutical company and a leader in the field of complex carbohydrate drug design.