Boston Therapeutics has been given the green light to initiate a clinical study of the efficacy and safety of SUGARDOWN® in combination with a standard meal on post-meal sugar and insulin blood levels in patients with Type ll diabetes that have been treated with metformin, the world's leading anti-diabetes prescription.
Boston Therapeutics has received approval by the French East IV Committee of Protection of Persons (Strasbourg) and the Ministry of Health; the company anticipates filing similar applications in the U.S., Hong Kong, and South Korea in 2013.
SUGARDOWN® previously was clinically proven to reduce the after meal elevation of blood sugar. For the next round of clinical trials, the company plans to enroll 24 patients with Type ll diabetes in the French study and expects to start recruiting patients in January 2013.
"In a clinical study, we saw significant reductions of post-meal elevation of blood sugar in healthy, non-diabetic patients who were overweight," Dr. Hana Chen Walden, consulting medical director of Boston Therapeutics stated in the press release. "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."
In October 2012, Boston Therapeutics announced that the FDA had approved its petition to file an Abbreviated New Drug Application (ANDA) for a new, chewable tablet formulation of metformin.
For more information visit bostonti.com
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