Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
- Conditions
- Type 2 Diabetes
- Interventions
- Dietary Supplement: BKR-017
- Registration Number
- NCT04673656
- Lead Sponsor
- BioKier Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Group 4 BKR-017 Group 4 will receive 84 days of 1.5 g of BKR-017 BID Test Group 1 BKR-017 Group 1 will receive 84 days of placebo BID Test Group 2 BKR-017 Group 2 will receive 84 days of 0.5 g of BKR-017 BID Test Group 3 BKR-017 Group 3 will receive 84 days of 1.0 g of BKR-017 BID
- Primary Outcome Measures
Name Time Method Changes in HOMA-IR Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84 Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA
- Secondary Outcome Measures
Name Time Method Changes in HbA1c Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 Changes in HbA1c at Days 1, 42, and 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 glucose at Days 1, 42, and 84
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 low-density lipoprotein-cholesterol (LDL-C) at Days 1, 42, and 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 fasting triglycerides at Days 1, 42, and 84
Changes in fasting insulin Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 Changes in fasting insulin at Days 1, 42, and 84
Trial Locations
- Locations (3)
Duke Clinical Research at Pickett Road
🇺🇸Durham, North Carolina, United States
Duke Clinical & Translational Science Institute (CTSI)
🇺🇸Kannapolis, North Carolina, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States