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Type2 Diabetes MellitusPhase 2NCT03655535

Multicenter Study to Evaluate the Effect of BTI320 on Glycemic Control in Type 2 Diabetes

A Phase 2 study testing BTI320 in people with Type2 Diabetes Mellitus, run by Boston Therapeutics at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the current study is to investigate the efficacy and safety of BTI320 compared to placebo in addition to metformin and/or sulfonylureas on glycemic control over 12 weeks in subjects with type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type2 Diabetes Mellitus
What is being tested?
BTI320
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
4 sitesUnited States
Study dates
19 Sep 2018to 30 Aug 2019
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years old.
  • Established type 2 diabetes as assessed by:
  • Fasting blood glucose (>126 mg/dL/7 mmol/L), or
  • 2 hr oral glucose tolerance test (>200 mg/dL/11.1 mmol/L), or
  • HbA1c is ≥7.0% within 3 months of enrollment and on a stable dose of metformin and/or sulfonylureas for at least 12 weeks.
  • Body Mass Index (BMI) >23 kg/m2.
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  • Treated with metformin and/or sulfonylureas (monotherapy or combination therapy) stable and maximally tolerated for at least three months prior to study participation. Subjects should be on stable and maximally tolerated doses throughout the study unless sulfonylureas require adjustment to reduce the risk of hypoglycemia during the study.
  • Subjects who are otherwise in generally satisfactory health.
  • Likely to follow study requirements, in particular, to adhere to maintaining a suitable diet and keeping an online diary of their food intake and weight measured once weekly via EDC.
  • Female subjects have negative urine pregnancy test at the Screening visit.
  • Provides signed informed consent to participate in the study. Informed consent must be given by the subject prior to inclusion in the study, and before performing any study procedures, including the screening visit.

Who cannot join

  • Have type 1 diabetes (insulin-dependent diabetes mellitus [IDDM]).
  • Treated with long-acting glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, alpha-glucosidase inhibitor, regular insulin, rapid-acting insulin analog, or sodium-glucose cotransport-2 inhibitors (SGLT-2). Treatment with any of these drugs should have been stopped at least 3 months before inclusion.
  • Current or recent (within past 30 days) participation in another investigational drug or device study.
  • Have participated in a previous study of BTI320.
  • Have any uncontrolled cardiovascular risk factors (hypertension, hyperlipidemia), past clinical manifestation of coronary artery disease, blood dyscrasias, or significant cerebrovascular disease in the previous year. Any concomitant drug treatment for a condition not related to diabetes should be discussed and approved with the study Medical Monitor.
  • Pregnant or breastfeeding, or plan to become pregnant within one year after randomization.
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  • Food allergy or severe food intolerance assessed by the Principal Investigator.
  • History of allergy or intolerance to BTI320 (PAZ320 or SugarDown) or equivalent.
  • Have known condition(s) influencing their glycemic levels (e.g. Cushing syndrome, pancreatic diseases, acromegaly).
  • Have human immunodeficiency virus (HIV) infection, hepatitis, tuberculosis, or other serious infectious disease.
  • History of alcohol addiction or drug abuse (illegal or controlled pharmaceutical substances) within past year prior to randomization.
  • Have planned major surgery within 6 months after randomization.
  • Have a terminal illness.
  • Serum creatinine of >1.4 mg/dL (>124 μmol/L) in women or >1.5 mg/dL (>133 μmol/L) in men or subjects with end-stage renal disease (Estimated Glomerular Filtration Rate calculated by CKD-EPI [eGFR] <10 mL/min/1.73 m2).
  • Have serum Alanine Aminotransferase (SGPT) >3 times upper limit of normal.
  • History of cancer, other than non-melanoma skin cancer, that requires treatment during the previous five years prior to randomization.
  • History of hemolytic anemia, repeated blood transfusions, or other conditions making HbA1c results unreliable as an indicator of chronic glucose level; hematocrit (Hct) <35% for men and <33% for women.
  • History of solid organ transplant.
  • Treatment with systemic glucocorticoids (except for short-term therapy [5 days or less]).
  • Treatment with atypical anti-psychotics.
  • In the opinion of the principal investigator, the subject is unlikely to follow the study protocol.
  • Employment/lifestyle that requires nocturnal hours.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Coastal Metabolic Research Center, Inc.

    Ventura, California, 93003

Other trials in United States

About this study

Official title: Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Effect of BTI320 in Addition to Current Treatment With Metformin and/or Sulfonylureas on Glycemic Control in Subjects With Type 2 Diabetes

The objective of the current study is to investigate the efficacy and safety of BTI320 compared to placebo in addition to metformin and/or sulfonylureas on glycemic control over 12 weeks in subjects with type 2 diabetes mellitus. This is a randomized, placebo-controlled, double-blind, multi-center study with two treatment arms. Study duration will be approximately 12 weeks. Participants will ingest 4 g BTI320 or matching placebo approximately 10 minutes before starting a meal, 3 times per day, at breakfast, lunch, and dinner. Eight study visits will be scheduled after the Screening visit: Baseline (day 0), weeks 3, 6, and 12 (Visits 2, 4, 6, and 8 respectively) for safety and efficacy assessments and Visits 3, 5, 7 and 9 to remove the Continuous Glucose Monitoring System.

Read the detailed description

The objective of the current study is to investigate the efficacy and safety of BTI320 compared to placebo in addition to metformin and/or sulfonylureas on glycemic control over 12 weeks in subjects with type 2 diabetes mellitus. This is a randomized, placebo-controlled, double-blind, multi-center study with two treatment arms. Study duration will be approximately 12 weeks. Participants will ingest 4 g BTI320 or matching placebo approximately 10 minutes before starting a meal, 3 times per day, at breakfast, lunch, and dinner. Participants will be instructed not to take the Investigational Medicinal Product with other drugs at the same time. Additional mealtime medication must be taken after consumption of the meal. A nutritionist, dietitian, or study personnel will provide instructions to subjects regarding dietary intake and the need to keep a detailed food record in an online calorie counter and have it entered into an electronic data capture during the study period. In general, subjects will be asked to follow normal meal plans recommended to patients with diabetes. Non-compliance will be defined as taking <80% or >120% of Investigational Medicinal Product during any outpatient evaluation period (visit to visit). Subjects who are non-compliant will be replaced to meet the goal of 60 evaluable subjects. Eight study visits will be scheduled after the Screening visit: Baseline (day 0), weeks 3, 6, and 12 (Visits 2, 4, 6, and 8 respectively) for safety and efficacy assessments and Visits 3, 5, 7 and 9 to remove the Continuous Glucose Monitoring System.

Being tested
BTI320, Placebo
Keywords
BTI320, Sugardown, Post-prandial glucose excursions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BTI320Drug

    Also called Sugardown, PAZ320

    Non-systemic galactomannan complex polysaccharide

  • PlaceboOther

    Placebo

Study groups in NCT03655535
Study groupRoleWhat they receive
BTI320Experimental4 g BTI320 administered 10 min before breakfast, lunch, and dinner
Receives: Drug: BTI320
PlaceboPlacebo comparatorPlacebo administered 10 min before breakfast, lunch, and dinner
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2 hr PPG

    Change from baseline to week 12 in area under the curve (AUC) 2-hr post-prandial glucose (PPG) excursions in subjects receiving BTI320 compared with those subjects receiving placebo.

    Measured: Week 12

Secondary outcomes (12)

  1. HbA1c

    Change in Hemoglobin A1c (HbA1c) serum levels from baseline

    Measured: Weeks 3, 6, and 12

  2. 2 hr PPG

    Change from baseline of AUC 2-hr PPG

    Measured: Weeks 3 and 6

  3. 1 hr PPG

    Change from baseline of AUC 1-hr PPG

    Measured: Weeks 3, 6, and 12

  4. 3 hr PPG

    Change from baseline of AUC 3-hr PPG

    Measured: Weeks 3, 6, and 12

  5. BMI

    Change in Body Mass Index (BMI) from baseline

    Measured: Week 12

  6. Lipids

    Change in serum lipid levels from baseline

    Measured: Weeks 3, 6, and 12

  7. Blood Pressure

    Change in systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial blood pressure (MAP) from baseline

    Measured: Week 12

  8. hsCRP concentration

    Change in serum highly sensitive C-reactive protein (hsCRP) levels from baseline

    Measured: Weeks 3, 6, and 12

  9. C-peptide/insulin concentration

    Change in serum C-peptide or insulin levels from baseline

    Measured: Weeks 3, 6, and 12

  10. Fasting blood glucose concentration

    Change in fasting blood glucose from baseline

    Measured: Weeks 3, 6, and 12

  11. CGMS

    Change in the AUC in Continuous Glucose Monitoring System (CGMS) from baseline

    Measured: Three days starting at Baseline, Weeks 3, 6, and 11

  12. Change in oral hypoglycemic medication

    Change in oral hypoglycemic medication dosage

    Measured: Weeks 3, 6, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start19 Sep 2018
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03655535
Sponsor's protocol ID
BTI320-SG02
Status last verified
Sep 2020
First submitted
29 Aug 2018
Last updated
25 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BTI320 in people with Type2 Diabetes Mellitus, run by Boston Therapeutics at 4 sites 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 11 inclusion and 22 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 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

2 hr PPG (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03655535.

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 25 Sep 2020.

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