NCT02135549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

May 8, 2014

Last Update Submit

February 7, 2018

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

    One week

Secondary Outcomes (3)

  • 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

Study Arms (3)

SugarDown 4 grams

EXPERIMENTAL

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

Dietary Supplement: SugarDown

SugarDown 8 grams

EXPERIMENTAL

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

Dietary Supplement: SugarDown

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

SugarDownDIETARY_SUPPLEMENT

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

SugarDown 4 gramsSugarDown 8 grams
Placebo Oral TabletDRUG

Placebo comparator

Placebo

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Accumed

Garden City, New York, 11530, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Charles Perry, MD

    Target Health Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 12, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

US(1)