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

September 24, 2020 updated by: Boston Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • Coastal Metabolic Research Center, Inc.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: BTI320
4 g BTI320 administered 10 min before breakfast, lunch, and dinner
Drug: BTI320
Non-systemic galactomannan complex polysaccharide
Other Names:
  • Sugardown
  • PAZ320
PLACEBO_COMPARATOR: Placebo
Placebo administered 10 min before breakfast, lunch, and dinner
Other: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
2 hr PPG
Time Frame: Week 12
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.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Weeks 3, 6, and 12
Change in Hemoglobin A1c (HbA1c) serum levels from baseline
Weeks 3, 6, and 12
2 hr PPG
Time Frame: Weeks 3 and 6
Change from baseline of AUC 2-hr PPG
Weeks 3 and 6
1 hr PPG
Time Frame: Weeks 3, 6, and 12
Change from baseline of AUC 1-hr PPG
Weeks 3, 6, and 12
3 hr PPG
Time Frame: Weeks 3, 6, and 12
Change from baseline of AUC 3-hr PPG
Weeks 3, 6, and 12
BMI
Time Frame: Week 12
Change in Body Mass Index (BMI) from baseline
Week 12
Lipids
Time Frame: Weeks 3, 6, and 12
Change in serum lipid levels from baseline
Weeks 3, 6, and 12
Blood Pressure
Time Frame: Week 12
Change in systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial blood pressure (MAP) from baseline
Week 12
hsCRP concentration
Time Frame: Weeks 3, 6, and 12
Change in serum highly sensitive C-reactive protein (hsCRP) levels from baseline
Weeks 3, 6, and 12
C-peptide/insulin concentration
Time Frame: Weeks 3, 6, and 12
Change in serum C-peptide or insulin levels from baseline
Weeks 3, 6, and 12
Fasting blood glucose concentration
Time Frame: Weeks 3, 6, and 12
Change in fasting blood glucose from baseline
Weeks 3, 6, and 12
CGMS
Time Frame: Three days starting at Baseline, Weeks 3, 6, and 11
Change in the AUC in Continuous Glucose Monitoring System (CGMS) from baseline
Three days starting at Baseline, Weeks 3, 6, and 11
Change in oral hypoglycemic medication
Time Frame: Weeks 3, 6, and 12
Change in oral hypoglycemic medication dosage
Weeks 3, 6, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sugardown Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTI320-SG02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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