Multicenter Study to Evaluate the Effect of BTI320 on Glycemic Control in Type 2 Diabetes
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): BTI320; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Non-systemic galactomannan complex polysaccharide; Placebo
Other intervention name(s): Sugardown; PAZ320
Intervention MeSH terms: PAZ320
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: BTI320; Sugardown; Post-prandial glucose excursions