Boston Therapeutics, a developer of complex carbohydrate therapeutics to treat diabetes, has completed enrollment of its phase IIb clinical study on BTI-320 in the United States. The study, SD-002, is being conducted by Accumed Research Associates in Garden City, New York.
The US trial enrolled patients with type 2 diabetes who are currently being treated with metformin. The patients were administered BTI-320 using a randomised, double-blind, placebo-controlled, dose-ranging, three-way cross-over study design. Patients' blood glucose were monitored and their postprandial (after-meal) blood glucose levels were measured following a test meal. The primary endpoint of the study is the evaluation of the effect of BTI-320 compared to placebo in the area under the curve (AUC) of glucose and secondarily, on insulin levels in the blood for four hours following intake of the meal.
David Platt, Ph.D., chief executive officer of Boston Therapeutics, said, "We are pleased to have completed enrollment in this trial and look forward to reporting its results. As with its companion trial in France, this US trial is designed to build upon the positive results from our Dartmouth Medical Center phase IIa trial for BTI-320, published last year in the peer-reviewed journal Endocrine Practice. In that phase IIa study, BTI-320 was well tolerated in patients taking various anti-diabetic agents, including metformin. These Phase IIb trials, which focus on patients taking only metformin, are 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."
BTI-320 is a non-systemic, new generation alpha glucosidase inhibitor-based tablet developed to reduce post-meal elevation of blood glucose. BTI-320 is a proprietary polysaccharide to be taken before meals and works in the gastrointestinal tract, non-systemically, to block the action of carbohydrate-hydrolysing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.