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

NCT03655535 | Completed Phase 2 FDA Drug

• 1 other identifier: BTI320-SG02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Type2 Diabetes Mellitus

Keywords

BTI320; Sugardown; Post-prandial glucose excursions

Outcome Measures

Primary Outcomes (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.

  Week 12

Secondary Outcomes (12)

• HbA1c

  Weeks 3, 6, and 12

• 2 hr PPG

  Weeks 3 and 6

• 1 hr PPG

  Weeks 3, 6, and 12

• 3 hr PPG

  Weeks 3, 6, and 12

• BMI

  Week 12

Study Arms (2)

BTI320

EXPERIMENTAL

4 g BTI320 administered 10 min before breakfast, lunch, and dinner

Drug: BTI320

Placebo

PLACEBO COMPARATOR

Placebo administered 10 min before breakfast, lunch, and dinner

Other: Placebo

Interventions

BTI320 DRUG

Non-systemic galactomannan complex polysaccharide

Also known as: Sugardown, PAZ320

BTI320

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old.
• Established type 2 diabetes as assessed by:
• Fasting blood glucose (\>126 mg/dL/7 mmol/L), or
• 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.

You may not qualify if:

• Have type 1 diabetes (insulin-dependent diabetes mellitus \[IDDM\]).
• 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.

Sponsors & Collaborators

• Boston Therapeutics: lead
• Sugardown Company Limited: collaborator

Study Sites (4)

Coastal Metabolic Research Center, Inc.

Ventura, California, 93003, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

MeSH Terms

Interventions

PAZ320

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: randomized, placebo-controlled, double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: September 19, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

US (4)