Type 2 DiabetesNCT04279444
Effects of BKR-017 on Insulin Resistance in Type 2 Diabetes Patients
A study testing BKR-017 in people with Type 2 Diabetes, run by BioKier Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of BKR-017 on insulin resistance in type 2 diabetes (T2D) subjects during 28 days of active test product administration. 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?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 15 Nov 2020
- 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
- HbA1c 6.5-10.5%, inclusive
- HOMA-IR 2.7 and above
- Has given written informed consent to participate in this study
- Willing to complete 28-day test period, including two overnight stays
- 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, or chronic/frequent diarrhea or chronic/frequent constipation
- Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
- History of significant heart disease, including congestive heart failure, prior MI, chronic atrial or ventricular fibrillation, coronary artery disease, cerebral vascular disease or other cardiovascular 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
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- 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
- 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)
- Allergy or intolerance to Boost® High Protein drink
- Pregnant, nursing, or trying to become pregnant
- Presence of pitting edema on physical exam
- High fiber diet
- 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. See list of excluded therapies in section 4.4.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Open-Label Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
The purpose of this study is to evaluate the effect of BKR-017 on insulin resistance in type 2 diabetes (T2D) subjects during 28 days of active test product administration.
Read the detailed description
The study consists of a screening period followed by a 28-day treatment period. All subjects will receive test product.
There are a total of 4 study visits including screening. Visit 1 is the screening visit. Eligible subject must have an HbA1c between 6.5 -10.5% and with HOMA-IR ≥ 2.7 (calculated from fasting insulin and fasting glucose). Visits 2 and 4 are overnight visits during which time a Mixed Meal Tolerance (MMTT) will be performed after an overnight fast. The MMTT requires an indwelling IV catheter so that 11 blood draws can be more comfortably be obtained over a period of 4 hours. At Visit 3,subjects will be evaluated and test product will be replenished. Routine chemistry and hematology testing are done and two time periods during the study and a physical exam is performed at screening
- 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
BioKier, Inc. is developing colon-targeted, oral formulations of natural gut hormone secretagogues as non-prescription medical foods or supplements for nutritional use for improvement of insulin sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Active BKR-017 | Experimental | Open label study. All patients will receive 28 days of active treatment. Receives: Dietary Supplement: BKR-017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance (HOMA-IR)
Changes, Day 0 to Day 28 in patient's insulin resistance (HOMA-IR)
Measured: 28 days of active test product administration
Secondary outcomes (4)
Fasting glucose
Changes in fasting glucose
Measured: Day 0 to Day 28
Fasting insulin
Changes in fasting insulin
Measured: Day 0 to Day 28
Fasting triglycerides
Changes in fasting triglycerides
Measured: Day 0 to Day 28
Triglyceride, glucose, and insulin AUCs
Changes in triglyceride, glucose, and insulin AUCs
Measured: 4 hours in the MMTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start16 Jun 2020
- Primary completion10 Nov 2020
- Study completion15 Nov 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioKier Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Szewczyk, PhD, Study chair, BioKier Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279444
- Sponsor's protocol ID
- CL-401
- Status last verified
- Dec 2020
- First submitted
- 19 Feb 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT04279444
- Acronym / sponsor ID
- CL-401
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BioKier Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 21 Feb 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.
The purpose of this study is to evaluate the effect of BKR-017 on insulin resistance in type 2 diabetes (T2D) subjects during 28 days of active test product administration.
Detailed description
The study consists of a screening period followed by a 28-day treatment period. All subjects will receive test product.
There are a total of 4 study visits including screening. Visit 1 is the screening visit. Eligible subject must have an HbA1c between 6.5 -10.5% and with HOMA-IR ≥ 2.7 (calculated from fasting insulin and fasting glucose). Visits 2 and 4 are overnight visits during which time a Mixed Meal Tolerance (MMTT) will be performed after an overnight fast. The MMTT requires an indwelling IV catheter so that 11 blood draws can be more comfortably be obtained over a period of 4 hours. At Visit 3,subjects will be evaluated and test product will be replenished. Routine chemistry and hematology testing are done and two time periods during the study and a physical exam is performed at screening
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active BKR-017 | Experimental | Dietary Supplement: BKR-017Open label study. All patients will receive 28 days of active treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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
- HbA1c 6.5-10.5%, inclusive
- HOMA-IR 2.7 and above
- Has given written informed consent to participate in this study
Key exclusion criteria (16 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, or chronic/frequent diarrhea or chronic/frequent constipation
- Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
- History of significant heart disease, including congestive heart failure, prior MI, chronic atrial or ventricular fibrillation, coronary artery disease, cerebral vascular disease or other cardiovascular 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-017BioKier, Inc. is developing colon-targeted, oral formulations of natural gut hormone secretagogues as non-prescription medical foods or supplements for nutritional use for improvement of insulin sensitivity. | Dietary supplement | Active BKR-017 |
Primary outcome
Insulin resistance (HOMA-IR)
Time frame: 28 days of active test product administration
Changes, Day 0 to Day 28 in patient's insulin resistance (HOMA-IR)
4 secondary outcomes
Fasting glucose
Time frame: Day 0 to Day 28
Fasting insulin
Time frame: Day 0 to Day 28
Fasting triglycerides
Time frame: Day 0 to Day 28
Triglyceride, glucose, and insulin AUCs
Time frame: 4 hours in the MMTT
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 4 Dec 2020.
- Individual participant dataSharing planned: No
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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.
George Szewczyk, PhD study chair
BioKier Inc.
1 site 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 1 site 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 7 inclusion and 16 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 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Insulin resistance (HOMA-IR) (time frame: 28 days of active test product administration). 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 4 Dec 2020.