Trials / Completed
CompletedNCT04673656
Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
Randomized, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- BioKier Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized, double-blind, placebo-controlled, dose-response study of BKR-017 and placebo that will be conducted at two investigative sites. The total duration of subject involvement is approximately 15 weeks; the screening period can be up to 3 weeks prior to the start of test period, followed by a 12-week test period. During the test period, subjects will self-administer three tablets of test product, two times daily: before breakfast and before bedtime.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | BKR-017 | Nutrient butyrate into a colon-targeted tablet formulation (BKR-017) is intended to stimulate secretion of GLP-1 from L-cells in the lower gut. Butyrate delivered to the colon in tablet form will not cause the side-effects seen with formation of butyrate by fermentation. |
Timeline
- Start date
- 2021-04-18
- Primary completion
- 2022-12-10
- Completion
- 2023-02-07
- First posted
- 2020-12-17
- Last updated
- 2023-02-08
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04673656. Inclusion in this directory is not an endorsement.