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

February 7, 2018 updated by: Boston Therapeutics

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Garden City, New York, United States, 11530
        • Accumed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SugarDown 4 grams
SugarDown 4 gram dose in tablet form, before meals, daily for one week
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
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
Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postprandial serum glucose area under the curve in mg*hr/dL over four hours
Time Frame: One week
One week

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak postprandial serum glucose in mg/dL
Time Frame: One week
One week
Time to peak postprandial serum glucose in minutes
Time Frame: One week
One week
Peak blood serum excursion at 2 hours from baseline in mg/dL
Time Frame: One week
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Charles Perry, MD, Target Health Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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