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

NCT03655535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-09-25

No results posted yet for this study

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

Interventions

DRUG

BTI320

Non-systemic galactomannan complex polysaccharide

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Sugardown Company Limited

    collaborator INDUSTRY

  • Boston Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2019-08-30
Completion
2019-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655535 on ClinicalTrials.gov