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

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

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo Oral Tablet; Dietary supplement: SugarDown

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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

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	One week

Secondary Outcome Measures

Outcome Measure	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	One week

Collaborators and Investigators

• Sponsor: Boston Therapeutics
• Investigators: Study Director: Charles Perry, MD, Target Health Inc.

Study record dates

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

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SD-002