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

NCT04673656 | Completed

• 1 other identifier: CL-501
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in fasting low-density lipoprotein-cholesterol (LDL-C)

  Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84

• Changes in fasting triglycerides

  Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84

• Changes in HbA1c

  Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84

• Changes in fasting glucose

  Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84

• Changes in fasting insulin

  Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84

Study Arms (4)

Test Group 1

PLACEBO COMPARATOR

Group 1 will receive 84 days of placebo BID

Dietary Supplement: BKR-017

Test Group 2

ACTIVE COMPARATOR

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

Dietary Supplement: BKR-017

Test Group 3

ACTIVE COMPARATOR

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

Dietary Supplement: BKR-017

Test Group 4

ACTIVE COMPARATOR

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

Dietary Supplement: BKR-017

Interventions

BKR-017 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.

Also known as: Butyrate

Test Group 1; Test Group 2; Test Group 3; Test Group 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioKier Inc.: lead

Study Sites (3)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Duke Clinical Research at Pickett Road

Durham, North Carolina, 27705, United States

Location

Duke Clinical & Translational Science Institute (CTSI)

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: April 18, 2021
• Primary Completion: December 10, 2022
• Study Completion: February 7, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (3)