Boston Therapeutics starts Phase IIb trial of type 2 diabetes drug SUGARDOWN

The 24-patient five-week, randomized, double-blind Phase IIb trial is being conducted by Accumed Research Associates under the direction of Principal Investigator Mitchell Efros.

SUGARDOWN is the company’s currently marketed dietary supplement that is intended to support healthy blood sugar.

Previous clinical trials have demonstrated that the drug can maintain healthy glucose levels even after meals when sugar tends to spike.

Primary endpoint of the trial is postprandial serum glucose area under the curve, while secondary endpoints include peak postprandial serum glucose, time to peak postprandial serum glucose, and peak blood serum excursion at two hours from baseline.

Boston Therapeutics chief executive officer David Platt said the company is looking forward to enrolling and conducting the new trial on the safety and efficacy of SUGARDOWN, in order to corroborate the previous clinical findings it has obtained.

"We expect this study will strengthen the existing body of evidence that SUGAR DOWN can play a useful role in supporting healthy blood sugar levels," Platte said.

"Having recently signed a strategic marketing agreement for SUGAR DOWN with Bench works SD, a leading branding and marketing agency, we look forward to having the results of this clinical study help support our marketing and sales initiatives."

The company said that enrolled patients will undergo a screening visit, baseline visit and three treatment visits.

All the patients will receive placebo tablets at the baseline visit, eat a standard rice meal, and then serum glucose levels will be measured in frequent intervals over four hours immediately after the meal.

According to the company, patients will be randomised to one of six treatment sequences.