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

Type2 Diabetes Mellitus Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

• NCT number: NCT03655535
• Study type: Interventional
• Source: Boston Therapeutics
• Status: Completed
• Phase: Phase 2
• Start date: September 19, 2018
• Completion date: August 30, 2019