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