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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SugarDown
Placebo Oral Tablet
Sponsored by
Boston Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Accumed

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SugarDown 4 grams

SugarDown 8 grams

Placebo

Arm Description

SugarDown 4 gram dose in tablet form, before meals, daily for one week

SugarDown 8 gram dose in tablet form, before meals, daily for one week

Placebo dose in tablet form, before meals, daily for one week

Outcomes

Primary Outcome Measures

Postprandial serum glucose area under the curve in mg*hr/dL over four hours

Secondary Outcome Measures

Peak postprandial serum glucose in mg/dL
Time to peak postprandial serum glucose in minutes
Peak blood serum excursion at 2 hours from baseline in mg/dL

Full Information

First Posted
May 8, 2014
Last Updated
February 7, 2018
Sponsor
Boston Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02135549
Brief Title
Study of the Effectiveness and Safety of SugarDown vs. Placebo in Type 2 Diabetic Subjects Treated With Metformin
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 Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SugarDown 4 grams
Arm Type
Experimental
Arm Description
SugarDown 4 gram dose in tablet form, before meals, daily for one week
Arm Title
SugarDown 8 grams
Arm Type
Experimental
Arm Description
SugarDown 8 gram dose in tablet form, before meals, daily for one week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dose in tablet form, before meals, daily for one week
Intervention Type
Dietary Supplement
Intervention Name(s)
SugarDown
Intervention Description
4 or 8 gram dose in tablet form, before meals, daily for one week
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Postprandial serum glucose area under the curve in mg*hr/dL over four hours
Time Frame
One week
Secondary Outcome Measure Information:
Title
Peak postprandial serum glucose in mg/dL
Time Frame
One week
Title
Time to peak postprandial serum glucose in minutes
Time Frame
One week
Title
Peak blood serum excursion at 2 hours from baseline in mg/dL
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Perry, MD
Organizational Affiliation
Target Health Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Accumed
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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