Boston Therapeutics announced it has begun enrolling patients in a Phase 2b Trial for its PAZ320 drug today. A total of 24 patients with type 2 diabetes currently being treated with metformin will be administered PAZ320 under double-blind, placebo-controlled conditions. The study is taking place at Centre Hospitalier Robert Bisson, Lisieux, France.
Study performers will monitor the patients' blood glucose using continuous glucose monitors, and their after-meal blood glucose levels measured using following a test meal. The primary endgoal of the trial is to evaluate the effect of PAZ320 compared to placebo the area under the curve (AUC) of glucose and on insulin levels in the blood for four hours following intake of the meal. Metformin is the most widely prescribed drug for diabetes, as well as the first drug often prescribed to new patients diagnosed with diabetes.
David Platt, Ph.D., Chief Executive Officer, BTHE, said, "This trial is designed to build upon the positive results from our Dartmouth Medical Center Phase 2a trial for PAZ320, recently published in the peer-reviewed journal, Endocrine Practice. In the Phase 2a study, PAZ320 was well tolerated in patients taking various anti-diabetic agents, including metformin. The Phase 2b trial, which focuses on patients taking only metformin, is the next step in the investigation of this compound as a potential adjunct to metformin in patients living with Type 2 diabetes. We believe it is important to better control glucose levels throughout the day, given the many complications that stem from uncontrolled diabetes."
PAZ320 is a non-systemic, non-toxic, chewable drug for prevention of diabetes and its complications. It targets enzymes that digest sugar during digestion, thereby reducing the amount of available glucose for the intestine to absorb. According to the American Diabetes Association, 25.8 million children and adults in the United States have diabetes, of which 27% of that population remains undiagnosed.
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