US-based Boston Therapeutics has completed enrolment in a Phase 2 trial to evaluate PAZ320 in patients with type 2 diabetes.
PAZ320 is a non-systemic, chewable, complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose.
The trial, held at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, US, is designed to evaluate the safety and efficacy of PAZ320 when added to oral agents or insulin in patients with type 2 diabetes.
Boston Therapeutics chairman and CEO, David Platt, said the preclinical models demonstrated significant reductions of post-meal elevation of glucose with PAZ320.
"It is important to manage glucose levels, given the many complications that result from uncontrolled diabetes. We are hopeful that PAZ320 will help the millions of people who have high blood sugar and diabetes," Platt added.
The interim data analysis of the Phase 2 trial reported no serious adverse events from PAZ320, a proprietary polysaccharide to be taken before meals, which works in the gastrointestinal tract to block the action of carbohydrate-hydrolysing enzymes that break down carbohydrates into glucose and release them into the bloodstream.
A total of 24 adult patients with type 2 diabetes, on insulin or oral agents, with a body mass index of 25-40kg/m² and with an A1C of less than or equal to 9% were included in the open-label, dose escalation crossover trial.
The company anticipates reporting the final Phase 2 results by September 2012.