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Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients

NCT04673656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • BioKier Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-18
Primary Completion
2022-12-10
Completion
2023-02-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673656 on ClinicalTrials.gov