Boston Therapeutics, Inc., an innovative developer of compounds that address diabetes using complex carbohydrate chemistry, has received Institutional Review Board (IRB) approval to initiate a clinical study of BTI-320 (previously named PAZ320) in the United States. The company expects the trial to last for approximately three months.
The US-based trial is intended to mirror the company's study of BTI-320 currently enrolling patients in France.
As with the France-based trial, the US trial plans to enroll 24 patients with Type 2 diabetes who are currently being treated with metformin. These patients will be administered BTI-320 using a randomized, double-blind, placebo-controlled, dose-ranging, three-way cross-over study design. Patients' blood glucose will be monitored and their postprandial (after-meal) blood glucose levels will be 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.
According to the International Diabetes Federation, a body of evidence suggests that reducing post-meal plasma glucose excursions is as important, or perhaps more important for achieving HbA1c goals. The relationship between hyperglycemia and cardiovascular disease is complex with evidence suggesting that an acute increase of glycemia, may have a direct detrimental effect on cardiovascular disease, and that targeting both post-meal plasma glucose and fasting plasma glucose are important strategies for achieving optimal glycemic control.
Yael T Bobruff, Ph.D., clinical affairs manager, said, "As with our trial being conducted in France, this US trial is designed to build upon the results from our Dartmouth Medical Centre trial for BTI-320, published last year in the peer-reviewed journal Endocrine Practice. In the Dartmouth study, BTI-320 was well tolerated in patients taking various anti-diabetic agents, including metformin. The current clinical trials, which focus on patients taking only metformin, are the next steps in the investigation of this compound 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 chewable complex carbohydrate-based compound designed 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 to block the action of carbohydrate-hydrolyzing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.