Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03655535
Other study ID # BTI320-SG02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 19, 2018
Est. completion date August 30, 2019

Study information

Verified date September 2020
Source Boston Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date August 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
BTI320
Non-systemic galactomannan complex polysaccharide
Other:
Placebo
Placebo

Locations

Country Name City State
United States Albuquerque Clinical Trials Albuquerque New Mexico
United States Coastal Carolina Research Center Mount Pleasant South Carolina
United States Advanced Research Institute Ogden Utah
United States Coastal Metabolic Research Center, Inc. Ventura California

Sponsors (2)

Lead Sponsor Collaborator
Boston Therapeutics Sugardown Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Week 12
Secondary HbA1c Change in Hemoglobin A1c (HbA1c) serum levels from baseline Weeks 3, 6, and 12
Secondary 2 hr PPG Change from baseline of AUC 2-hr PPG Weeks 3 and 6
Secondary 1 hr PPG Change from baseline of AUC 1-hr PPG Weeks 3, 6, and 12
Secondary 3 hr PPG Change from baseline of AUC 3-hr PPG Weeks 3, 6, and 12
Secondary BMI Change in Body Mass Index (BMI) from baseline Week 12
Secondary Lipids Change in serum lipid levels from baseline Weeks 3, 6, and 12
Secondary Blood Pressure Change in systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial blood pressure (MAP) from baseline Week 12
Secondary hsCRP concentration Change in serum highly sensitive C-reactive protein (hsCRP) levels from baseline Weeks 3, 6, and 12
Secondary C-peptide/insulin concentration Change in serum C-peptide or insulin levels from baseline Weeks 3, 6, and 12
Secondary Fasting blood glucose concentration Change in fasting blood glucose from baseline Weeks 3, 6, and 12
Secondary CGMS Change in the AUC in Continuous Glucose Monitoring System (CGMS) from baseline Three days starting at Baseline, Weeks 3, 6, and 11
Secondary Change in oral hypoglycemic medication Change in oral hypoglycemic medication dosage Weeks 3, 6, and 12
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04082091 - Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention
Active, not recruiting NCT02248311 - "Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population N/A
Completed NCT02653300 - A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH) Phase 2
Completed NCT03256747 - Effects of Neuromuscular Electrical Stimulation on Glucose Variability in Patients With Type 2 Diabetes N/A
Completed NCT05343767 - Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus N/A
Withdrawn NCT03675074 - Neujia Anastomosis for Treatment of Obesity and Type II Diabetes N/A
Withdrawn NCT03190798 - Effects of Canagliflozin on Intravascular Volume and Hemodynamics Phase 4
Withdrawn NCT03437330 - Empagliflozin Effect on Glucose Toxicity Phase 4
Withdrawn NCT03008395 - Empowerment, Motivation and Medical Adherence (EMMA). N/A
Not yet recruiting NCT05539066 - AI Health Assistant and Type 2 Diabetes N/A
Completed NCT03682445 - Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus N/A
Not yet recruiting NCT03239119 - The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus Phase 3
Completed NCT03259789 - Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects Phase 3
Recruiting NCT03506230 - Financial Incentives for Low Socioeconomic Diabetic Patients N/A
Completed NCT03072407 - MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM Phase 1
Completed NCT05668442 - Feasibility of an Online Exercise Community Among Individuals With Type 2 Diabetes
Completed NCT02964572 - Effect of Sodium Glucose Co-transporter 2 Inhibitor on Inflammatory Cytokine in Type 2 Diabetes N/A
Completed NCT02956044 - Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin Phase 1
Completed NCT02628392 - A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM) N/A
Completed NCT03104738 - Basal Insulin Strategies Before Surgery N/A