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

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ClinicalTrials.gov Identifier: NCT02135549
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: SugarDown Drug: Placebo Oral Tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Experimental: SugarDown 4 grams
SugarDown 4 gram dose in tablet form, before meals, daily for one week
Dietary Supplement: SugarDown
4 or 8 gram dose in tablet form, before meals, daily for one week

Experimental: SugarDown 8 grams
SugarDown 8 gram dose in tablet form, before meals, daily for one week
Dietary Supplement: SugarDown
4 or 8 gram dose in tablet form, before meals, daily for one week

Placebo Comparator: Placebo
Placebo dose in tablet form, before meals, daily for one week
Drug: Placebo Oral Tablet
Placebo comparator




Primary Outcome Measures :
  1. Postprandial serum glucose area under the curve in mg*hr/dL over four hours [ Time Frame: One week ]

Secondary Outcome Measures :
  1. Peak postprandial serum glucose in mg/dL [ Time Frame: One week ]
  2. Time to peak postprandial serum glucose in minutes [ Time Frame: One week ]
  3. Peak blood serum excursion at 2 hours from baseline in mg/dL [ Time Frame: One week ]


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to any trial-related activity
  • Male or female, between 25-75 years of age
  • A diagnosis of Type 2 Diabetes for at least one year prior to screening visit
  • Stable daily dose of metformin (up to 1.7 g daily) for at least 3 months prior to screening visit
  • Body Mass Index (BMI) between 25 and 35
  • HbA1c between 6.5% and 9.0%
  • Fasting blood glucose < 180 mg/dL

Exclusion Criteria:

  • Clinically significant cardiovascular, peripheral vascular, cerebrovascular or renal disease
  • Any clinical condition apart from diabetes Type 2 that affects glycemic control, examples include diabetes Type 1, liver disease, chronic pancreatitis, endocrine disease (e.g. pituitary, thyroid, adrenal gland disease), small or large intestine motility or absorptive disease, active infection, advanced malignant tumor or bariatric surgery
  • Any concomitant anti-diabetic medication other than metformin, including, but not limited to, the following classes of medication: insulin, sulfonylureas, glinides, glitazones, alpha-glucosidase inhibitors, amylin agonists, DPP-4 inhibitors, and GLP-1 agonists
  • Any concomitant steroid, hormonal, anorexic or other medications that could significantly interfere with glycemic control in subjects
  • Lactating or pregnant women, or women of child-bearing potential unable to use adequate birth control.
  • History or patient reported illicit drug abuse or alcoholism
  • Participation in another clinical study one month preceding recruitment
  • Any of the following laboratory abnormalities: AST or ALT > 1.5 times upper limit normal on liver function test, glomerular filtration rate < 60 (mL/min/1.73 m2) on chemistry panel measured by MDRD criteria, and hemoglobin < 10 g/dL on complete blood count

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135549


Locations
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United States, New York
Accumed
Garden City, New York, United States, 11530
Sponsors and Collaborators
Boston Therapeutics
Investigators
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Study Director: Charles Perry, MD Target Health Inc.
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Responsible Party: Boston Therapeutics
ClinicalTrials.gov Identifier: NCT02135549    
Other Study ID Numbers: SD-002
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases