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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
4 or 8 gram dose in tablet form, before meals, daily for one week
Placebo comparator
Accumed
Garden City, New York, United States
Postprandial serum glucose area under the curve in mg*hr/dL over four hours
Time frame: One week
Peak postprandial serum glucose in mg/dL
Time frame: One week
Time to peak postprandial serum glucose in minutes
Time frame: One week
Peak blood serum excursion at 2 hours from baseline in mg/dL
Time frame: One week
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