Back to resultsDose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BKR-017
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes
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.
Sites / Locations
- Pennington Biomedical Research Center
- Duke Clinical Research at Pickett Road
- Duke Clinical & Translational Science Institute (CTSI)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Test Group 1
Test Group 2
Test Group 3
Test Group 4
Arm Description
Group 1 will receive 84 days of placebo BID
Group 2 will receive 84 days of 0.5 g of BKR-017 BID
Group 3 will receive 84 days of 1.0 g of BKR-017 BID
Group 4 will receive 84 days of 1.5 g of BKR-017 BID
Outcomes
Primary Outcome Measures
Changes in HOMA-IR
Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA
Secondary Outcome Measures
Changes in fasting low-density lipoprotein-cholesterol (LDL-C)
Changes in fasting low-density lipoprotein-cholesterol (LDL-C) at Days 1, 42, and 84
Changes in fasting triglycerides
Changes in fasting triglycerides at Days 1, 42, and 84
Changes in HbA1c
Changes in HbA1c at Days 1, 42, and 84
Changes in fasting glucose
Changes in fasting glucose at Days 1, 42, and 84
Changes in fasting insulin
Changes in fasting insulin at Days 1, 42, and 84
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04673656
Brief Title
Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 18, 2021 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
February 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioKier Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Group 1
Arm Type
Placebo Comparator
Arm Description
Group 1 will receive 84 days of placebo BID
Arm Title
Test Group 2
Arm Type
Active Comparator
Arm Description
Group 2 will receive 84 days of 0.5 g of BKR-017 BID
Arm Title
Test Group 3
Arm Type
Active Comparator
Arm Description
Group 3 will receive 84 days of 1.0 g of BKR-017 BID
Arm Title
Test Group 4
Arm Type
Active Comparator
Arm Description
Group 4 will receive 84 days of 1.5 g of BKR-017 BID
Intervention Type
Dietary Supplement
Intervention Name(s)
BKR-017
Other Intervention Name(s)
Butyrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in HOMA-IR
Description
Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA
Time Frame
Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84
Secondary Outcome Measure Information:
Title
Changes in fasting low-density lipoprotein-cholesterol (LDL-C)
Description
Changes in fasting low-density lipoprotein-cholesterol (LDL-C) at Days 1, 42, and 84
Time Frame
Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Title
Changes in fasting triglycerides
Description
Changes in fasting triglycerides at Days 1, 42, and 84
Time Frame
Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84
Title
Changes in HbA1c
Description
Changes in HbA1c at Days 1, 42, and 84
Time Frame
Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Title
Changes in fasting glucose
Description
Changes in fasting glucose at Days 1, 42, and 84
Time Frame
Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Title
Changes in fasting insulin
Description
Changes in fasting insulin at Days 1, 42, and 84
Time Frame
Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Duke Clinical Research at Pickett Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Clinical & Translational Science Institute (CTSI)
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
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