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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: BKR-017

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Clinical Research at Pickett Road
    • Kannapolis, North Carolina, United States, 28081
      • Duke Clinical & Translational Science Institute (CTSI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females between the ages of 18 and 70 years at the time of screening, inclusive
• Diagnosed with T2D and under the care of a healthcare professional for its management, or newly diagnosed (as participant in the study) with T2D
• HbA1c 6.5% -10.5%, inclusive
• Has given written informed consent to participate in this study
• Willing to complete 84-day test period
• Willing to maintain current diet and exercise routine and current prescription medications for the duration of the study

Exclusion Criteria:

• Type 1 diabetes
• History of bariatric or intestinal surgery
• Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis
• Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
• History of heart disease that in the opinion of the investigator should exclude the subject from the study
• Severely uncontrolled hypertension at screening defined as a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes
• Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
• Active significant infection as determined by the investigator
• Known allergy to butyrate or any of the components of the tablets
• Subjects planning to make major changes to diet and physical activity during the trial duration
• Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
• Pregnant, nursing, or trying to become pregnant
• In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.
• Subject is taking one or more of the excluded therapies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Test Group 1; Group 1 will receive 84 days of placebo BID	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.; Other Names: Butyrate
ACTIVE_COMPARATOR: Test Group 2; Group 2 will receive 84 days of 0.5 g of BKR-017 BID	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.; Other Names: Butyrate
ACTIVE_COMPARATOR: Test Group 3; Group 3 will receive 84 days of 1.0 g of BKR-017 BID	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.; Other Names: Butyrate
ACTIVE_COMPARATOR: Test Group 4; Group 4 will receive 84 days of 1.5 g of BKR-017 BID	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.; Other Names: Butyrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in HOMA-IR	Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA	Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fasting low-density lipoprotein-cholesterol (LDL-C)	Changes in fasting low-density lipoprotein-cholesterol (LDL-C) at Days 1, 42, and 84	Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting triglycerides	Changes in fasting triglycerides at Days 1, 42, and 84	Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84
Changes in HbA1c	Changes in HbA1c at Days 1, 42, and 84	Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting glucose	Changes in fasting glucose at Days 1, 42, and 84	Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting insulin	Changes in fasting insulin at Days 1, 42, and 84	Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84

Collaborators and Investigators

• Sponsor: BioKier Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2021
• Primary Completion (ACTUAL): December 10, 2022
• Study Completion (ACTUAL): February 7, 2023

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: CL-501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No