Type 2 DiabetesNCT04673656
Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
A study testing BKR-017 in people with Type 2 Diabetes, run by BioKier Inc. at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- BKR-017
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Apr 2021to 7 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Duke Clinical Research at Pickett Road
Durham, North Carolina, 27705
Duke Clinical & Translational Science Institute (CTSI)
Kannapolis, North Carolina, 28081
About this study
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
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
- Being tested
- BKR-017
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BKR-017Dietary supplement
Also called Butyrate
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Group 1 | Placebo comparator | Group 1 will receive 84 days of placebo BID Receives: Dietary Supplement: BKR-017 |
| Test Group 2 | Active comparator | Group 2 will receive 84 days of 0.5 g of BKR-017 BID Receives: Dietary Supplement: BKR-017 |
| Test Group 3 | Active comparator | Group 3 will receive 84 days of 1.0 g of BKR-017 BID Receives: Dietary Supplement: BKR-017 |
| Test Group 4 | Active comparator | Group 4 will receive 84 days of 1.5 g of BKR-017 BID Receives: Dietary Supplement: BKR-017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HOMA-IR
Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA
Measured: 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)
Changes in fasting low-density lipoprotein-cholesterol (LDL-C) at Days 1, 42, and 84
Measured: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting triglycerides
Changes in fasting triglycerides at Days 1, 42, and 84
Measured: Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84
Changes in HbA1c
Changes in HbA1c at Days 1, 42, and 84
Measured: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting glucose
Changes in fasting glucose at Days 1, 42, and 84
Measured: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting insulin
Changes in fasting insulin at Days 1, 42, and 84
Measured: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start18 Apr 2021
- Primary completion10 Dec 2022
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioKier Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673656
- Sponsor's protocol ID
- CL-501
- Status last verified
- Feb 2023
- First submitted
- 10 Dec 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04673656
- Acronym / sponsor ID
- CL-501
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BioKier Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2021 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group 1 | Placebo comparator | Dietary Supplement: BKR-017Group 1 will receive 84 days of placebo BID |
| Test Group 2 | Active comparator | Dietary Supplement: BKR-017Group 2 will receive 84 days of 0.5 g of BKR-017 BID |
| Test Group 3 | Active comparator | Dietary Supplement: BKR-017Group 3 will receive 84 days of 1.0 g of BKR-017 BID |
| Test Group 4 | Active comparator | Dietary Supplement: BKR-017Group 4 will receive 84 days of 1.5 g of BKR-017 BID |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BKR-017Also: ButyrateNutrient 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. | Dietary supplement | Test Group 1, Test Group 2, Test Group 3, Test Group 4 |
Primary outcome
Changes in HOMA-IR
Time frame: 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
5 secondary outcomes
Changes in fasting low-density lipoprotein-cholesterol (LDL-C)
Time frame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting triglycerides
Time frame: Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84
Changes in HbA1c
Time frame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting glucose
Time frame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Changes in fasting insulin
Time frame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Related trials for Type 2 Diabetes
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Recruiting
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BKR-017 in people with Type 2 Diabetes, run by BioKier Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HOMA-IR (time frame: Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.