Multicenter Study to Evaluate the Effect of BTI320 on Glycemic Control in Type 2 Diabetes
Status:
Completed
Trial end date:
2019-08-30
Target enrollment:
Participant gender:
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.