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

NCT ID: NCT04673656

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-18
• Study Completion Date: 2023-02-07

Brief 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

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Test Group 1

Group 1 will receive 84 days of placebo BID

Group Type: PLACEBO_COMPARATOR

BKR-017

Intervention Type: DIETARY_SUPPLEMENT

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.

Test Group 2

Group 2 will receive 84 days of 0.5 g of BKR-017 BID

Group Type: ACTIVE_COMPARATOR

BKR-017

Intervention Type: DIETARY_SUPPLEMENT

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.

Test Group 3

Group 3 will receive 84 days of 1.0 g of BKR-017 BID

Group Type: ACTIVE_COMPARATOR

BKR-017

Intervention Type: DIETARY_SUPPLEMENT

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.

Test Group 4

Group 4 will receive 84 days of 1.5 g of BKR-017 BID

Group Type: ACTIVE_COMPARATOR

BKR-017

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Butyrate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioKier Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Duke Clinical Research at Pickett Road

Durham, North Carolina, United States

Duke Clinical & Translational Science Institute (CTSI)

Kannapolis, North Carolina, United States

Countries

United States

Other Identifiers

CL-501

Identifier Type: -

Identifier Source: org_study_id