Multicenter Study to Evaluate the Effect of BTI320 on Glycemic Control in Type 2 Diabetes
Public ClinicalTrials.gov record NCT03655535. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03655535
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 18, 2018
- Primary completion
- Aug 29, 2019
- Completion
- Aug 29, 2019
- Last update posted
- Sep 24, 2020
2018 – 2019
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coastal Metabolic Research Center, Inc. | Ventura | California | 93003 | — |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| Advanced Research Institute | Ogden | Utah | 84405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03655535, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2020 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03655535 live on ClinicalTrials.gov.