NCT02135549

Study of the Effectiveness and Safety of SugarDown vs. Placebo in Type 2 Diabetic Subjects Treated With Metformin

Randomized, Dose-Ranging, Cross-over, Placebo-controlled Study of the Effectiveness and Safety of SugarDown vs. Placebo in Type 2 Diabetic Subjects Treated With Metformin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boston Therapeutics · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and effectiveness of two doses of SugarDown in two different doses vs. placebo on serum glucose levels after meals in subjects with Type 2 Diabetes treated with metformin alone. There will be five visits, a screening visit, baseline visit, and 3 treatment visits. The study duration will be five weeks. Subjects 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 following the meal. Subjects will be randomized to one of the six treatment sequences. Patients will take in an unknown order one week of placebo, one week of 4 g dose and one week of 8 g dose of SugarDown immediately before breakfast, lunch and dinner meals. Patients will continue their usual metformin regimen during the trial period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	SugarDown	4 or 8 gram dose in tablet form, before meals, daily for one week
DRUG	Placebo Oral Tablet	Placebo comparator

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-05-12
• Last updated: 2018-02-08

Locations

1 site across 1 country: United States