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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SugarDown 4 grams | Experimental | SugarDown 4 gram dose in tablet form, before meals, daily for one week |
|
| SugarDown 8 grams | Experimental | SugarDown 8 gram dose in tablet form, before meals, daily for one week |
|
| Placebo | Placebo Comparator | Placebo dose in tablet form, before meals, daily for one week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SugarDown | Dietary Supplement | 4 or 8 gram dose in tablet form, before meals, daily for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial serum glucose area under the curve in mg*hr/dL over four hours | One week |
| Measure | Description | Time Frame |
|---|---|---|
| Peak postprandial serum glucose in mg/dL | One week | |
| Time to peak postprandial serum glucose in minutes | One week | |
| Peak blood serum excursion at 2 hours from baseline in mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Perry, MD | Target Health Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accumed | Garden City | New York | 11530 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo Oral Tablet | Drug | Placebo comparator |
|
| One week |
| D004700 | Endocrine System Diseases |