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

NCT02135549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-02-08

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

SugarDown

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

DRUG

Placebo Oral Tablet

Placebo comparator

Sponsors & Collaborators

  • Boston Therapeutics

    lead INDUSTRY

Principal Investigators

  • Charles Perry, MD · Target Health Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02135549 on ClinicalTrials.gov