US-based pharmaceutical company Boston Therapeutics has reported positive results from a Phase ll clinical trial of its complex carbohydrate-based drug for reducing post-meal elevation of blood glucose.

The non-systemic chewable complex drug, PAZ320, is a proprietary polysaccharide that blocks the action of carbohydrate-hydrolysing enzymes, which break down carbohydrates into glucose and release it into the bloodstream.

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The trial had enrolled 24 patients with type 2 diabetes aged between 18 and 75 with a body mass index (BMI) of 25kg – 40kg/m² and with HbA1c of less than or equal to 9%, to evaluate the safety and efficacy of PAZ320.

The study reported that 45% of patients responded with a 40% reduction of post-meal glucose in the blood, compared to baseline in a dose-dependent manner, with no severe hypoglycemia and only mild gastrointestinal side effects.

"PAZ320 is a proprietary polysaccharide that blocks the action of carbohydrate-hydrolysing enzymes, which break down carbohydrates into glucose and release it into the bloodstream."

The study also showed no serious adverse events from the data analysis of the open-label dose escalation crossover trial.

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In addition, the results showed the effect of PAZ320 does not correlate with duration of diabetes, and its efficacy is not affected by diabetes medications.

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Dartmouth Medical Centre department of medicine endocrinologist and study co-principal investigator Dr Sushela Chaidarun said uncontrolled diabetes can lead to micro and macro-vascular complications, so tighter but safe glycemic control is imperative.

"Optimal post-meal glucose control is one of the most difficult goals to achieve as type 2 diabetes progresses, and PAZ320 may be helpful in achieving this goal," Chaidarun said.

"Its safety profile is reassuring."