US-based Boston Therapeutics has started patient enrolment in a Phase IIb clinical trial of a complex carbohydrate-based drug called PAZ320, which is designed to reduce the elevation of post-meal blood glucose by blocking the action of carbohydrate-hydrolyzing enzymes.
In the double-blind, placebo-controlled trial, a total of 24 patients with Type 2 diabetes currently being treated with metformin will be given PAZ320 and their blood glucose will be checked using continuous glucose monitors (CGM) and their postprandial (after-meal) blood glucose levels will be measured after a test meal.
The trial's primary endpoint is to assess the effect of PAZ320 compared to placebo in the area under the curve (AUC) of glucose and on insulin levels in the blood for four hours following intake of the meal.
It is being carried out at Centre Hospitalier Robert Bisson in France is designed to build upon the positive results from the company's Dartmouth Medical Center Phase IIa trial of PAZ320.
According to the company, in the Phase IIa study, PAZ320 was well-tolerated in patients taking several anti-diabetic agents, including metformin.
Boston Therapeutics chief executive officer David Platt said the Phase IIb 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," Platt said.
Metformin is a widely prescribed drug for diabetes and is claimed to be the first drug prescribed for newly diagnosed diabetes patients.
The company said that PAZ320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose.