Type 2 Diabetes MellitusNCT02135549
Study of the Effectiveness and Safety of SugarDown vs. Placebo in Type 2 Diabetic Subjects Treated With Metformin
A study testing SugarDown in people with Type 2 Diabetes Mellitus, run by Boston Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- SugarDown
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Type 2 Diabetes Mellitus
- Being tested
- SugarDown, Placebo Oral Tablet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugarDownDietary supplement
4 or 8 gram dose in tablet form, before meals, daily for one week
Placebo Oral TabletDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| SugarDown 4 grams | Experimental | SugarDown 4 gram dose in tablet form, before meals, daily for one week Receives: Dietary Supplement: SugarDown |
| SugarDown 8 grams | Experimental | SugarDown 8 gram dose in tablet form, before meals, daily for one week Receives: Dietary Supplement: SugarDown |
| Placebo | Placebo comparator | Placebo dose in tablet form, before meals, daily for one week Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial serum glucose area under the curve in mg*hr/dL over four hours
Measured: One week
Secondary outcomes (3)
Peak postprandial serum glucose in mg/dL
Measured: One week
Time to peak postprandial serum glucose in minutes
Measured: One week
Peak blood serum excursion at 2 hours from baseline in mg/dL
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Perry, MD, Study director, Target Health Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135549
- Sponsor's protocol ID
- SD-002
- Status last verified
- Feb 2018
- First submitted
- 8 May 2014
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02135549
- Acronym / sponsor ID
- SD-002
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boston TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SugarDown 4 grams | Experimental | Dietary Supplement: SugarDownSugarDown 4 gram dose in tablet form, before meals, daily for one week |
| SugarDown 8 grams | Experimental | Dietary Supplement: SugarDownSugarDown 8 gram dose in tablet form, before meals, daily for one week |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo dose in tablet form, before meals, daily for one week |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugarDown4 or 8 gram dose in tablet form, before meals, daily for one week | Dietary supplement | SugarDown 4 grams, SugarDown 8 grams |
| Placebo Oral TabletPlacebo comparator | Drug | Placebo |
Primary outcome
Postprandial serum glucose area under the curve in mg*hr/dL over four hours
Time frame: One week
3 secondary outcomes
Peak postprandial serum glucose in mg/dL
Time frame: One week
Time to peak postprandial serum glucose in minutes
Time frame: One week
Peak blood serum excursion at 2 hours from baseline in mg/dL
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Perry, MD study director
Target Health Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SugarDown in people with Type 2 Diabetes Mellitus, run by Boston Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial serum glucose area under the curve in mg*hr/dL over four hours (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.