US-based Boston Therapeutics (BTI) has started a Phase IIb clinical trial SD-002 to evaluate the efficacy and safety of Sugardown in patients with type 2 diabetes taking metformin.
Accumed Research Associates is conducting the 24-patient five-week, randomised, double-blind Phase IIb trial 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 studies have showed that the drug can maintain healthy glucose levels even after meals when sugar tends to spike.
“We expect this study will strengthen the existing body of evidence that Sugardown can play a useful role in supporting healthy blood sugar levels.“
The trial’s primary endpoint 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: “We expect this study will strengthen the existing body of evidence that Sugardown can play a useful role in supporting healthy blood sugar levels.
“Having recently signed a strategic marketing agreement for Sugardown with Benchworks SD, 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.
They will all 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.
The company said that in the trial, patients will be randomised to one of six treatment sequences.
Patients will take in an unknown order one week of placebo, one week of 4g dose and one week of 8g dose of Sugardown immediately before breakfast, lunch and dinner meals.
According to the company, patients will continue their usual metformin regimen during the trial period.