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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673656
• Other study ID #: CL-501
• Status: Completed
• Phase: N/A
• Start date: April 18, 2021
• Est. completion date: February 7, 2023

Study information

• Verified date: February 2023
• Source: BioKier Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 7, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
BioKier Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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