Boston Therapeutics has commenced a new confirmatory, proof of concept adaptive trial to investigate the potential of BTI320 for the treatment of patients with Type 2 diabetes.

Type 2 diabetes is a chronic condition that impacts the way an individual’s body metabolises sugar (glucose), an important source of fuel for the body.

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The double-blind, placebo-controlled trial aims to study BTI320’s ability to support and possibly improve current anti-diabetic regimen of glycemic control in subjects with Type 2 diabetes.

The trial, which is being conducted in four sites in the US, has already enrolled its first subject out of 60.

As part of the trial, BTI320 will be studied in comparison with placebo and in combination with metformin and/or sulfonylureas on critical glycemic control over a period of 12 weeks.

“The trial’s objective is to evaluate appropriate efficacy of clinical benefit and further validate the safety of BTI320.”

The trial’s objective is to evaluate appropriate efficacy of clinical benefit and further validate the safety of BTI320.

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In addition, the trial aims to confirm the appropriate effects of BTI320 on specific postprandial glucose excursions and possibility of improved control of variability in Type 2 diabetics.

Boston Therapeutics CEO Carl Rausch said: “With the incidence of diabetes on the rise, there is an immediate need for the development of novel safe (non-systemic) drugs to provide safe, convenient and cost-effective new treatment modalities to help individuals with pre-diabetes and diabetes, thereby improving their diabetes management options and compliance.”

The company further noted that it used a ‘Big Data’ approach to collect glycemic parameters hourly for several days and over the variable meal programmes of each subject participating in the trial.