Type 2 Diabetes MellitusNCT03382015
Effect of BKR-013 on Average Daily Glucose Levels
A study of Type 2 Diabetes Mellitus, run by BioKier Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of BKR-013 on average daily glucose (ADG) levels in type 2 diabetes (T2D) subjects during 28 days of either placebo or 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 Mellitus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2018to 30 Jun 2018
- 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
- Has given written informed consent to participate in this study
- Agrees to comply with all study requirements, including maintaining current diet and exercise routine and current prescription medications for the duration of the study
- Willing to wear a Continuous Glucose Monitoring (CGM) sensor continuously for 28 days during each of the two test periods
- Willing to complete two 28-day test periods (separated by a wash-out period of 21 to 35 days) and participate in the study for a total duration of up to 18 weeks.
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
Show all 17Show fewer
- Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
- Active significant infection as determined by the investigator
- Known allergy to L-glutamine or any of the components of the capsules
- 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
- Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan or high-frequency electrical heat (diathermy) treatment scheduled during either of the 4-week test periods that a subject is wearing CGM sensor.
- 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.
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: Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Evaluate the Effect of BKR-013 on Average Daily Glucose Levels in Type 2 Diabetes Patients
The purpose of this study is to evaluate the effect of BKR-013 on average daily glucose (ADG) levels in type 2 diabetes (T2D) subjects during 28 days of either placebo or active test product administration. Subjects will serve as their own controls in this crossover design, and ADG will be compared while a subject is on active test product versus while they received placebo test product.
Read the detailed description
The study consists of a screening period followed by a 28-day treatment period, a 3 to 5 week washout period, and a second treatment period. All subjects receive both active test product and placebo, but the order in which they receive them (Part 1 or Part 2 of the study) is randomized in this single crossover study. Fourteen subjects will be randomized to ensure that 10 subjects complete both Part 1 and Part 2 of the study.
There are a total of 7 study visits including screening. In Part 1, Visits 2, 3 and 4 occur 2 weeks apart; in Part 2, Visits 5, 6 and 7 also occur 2 weeks apart. Visits 4 and 7 are overnight visits during which time hunger and satiety will be assessed and a Mixed Meal Tolerance Test (MMTT) will be performed after an overnight fast. The MMTT requires use of an indwelling IV catheter so that 11 blood draws can be more comfortably obtained over a period of 4 hours.
Subjects will be required to wear a glucose monitoring sensor during Part 1 and Part 2 of the study in order to obtain ADG levels.
Routine chemistry and hematology tests are done at 4 timepoints during the study. An ECG and physical exam is performed at screening.
A rapid HbA1c will only be tested at screening; if the value is between 6.5% and 10.5%, all other screening procedures will be performed; if the HbA1c value is not within the qualifying range, the subject will be considered a screen failure and no other screening procedures will be performed.
Subjects are required to keep a daily diary to document dosing (twice daily), medication changes and any adverse events.
Safety tests include chemistry/hematology, vital signs and adverse events.
Subjects with type 2 diabetes must be under the care of a healthcare professional to take part in this study. The test product BKR-013 is not designed to treat diabetes; it is being evaluated as a non-prescription medical food for nutritional use in managing glucose levels.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BKR-013 or Placebo
- 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-013 or PlaceboOther
Encapsulated L-glutamine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Receives 28 days of active test product (BKR-013) in Part 1 of the study and receives 28 days of placebo in Part 2 of the study, following a washout period. Receives: Other: BKR-013 or Placebo |
| Group 2 | Placebo comparator | Receives 28 days of placebo in Part 1 of the study and receives 28 days of active test product (BKR-013) in Part 2 of the study, following a washout period. Receives: Other: BKR-013 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Glucose Levels
Intra-patient comparison of ADG in Part 1 vs Part 2
Measured: After 28 days of treatment in Part 1 and in Part 2
Secondary outcomes (2)
Glucose >180 mg/dL
Percent of each 24-hour period that a subject's glucose is >180 mg/dL
Measured: After 28 days of treatment in Part 1 and in Part 2
Triglycerides
Differences in fasting triglycerides between active test product and placebo
Measured: After 28 days of treatment in Part 1 and in Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start9 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioKier Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George R Szewczyk, PhD, Study director, BioKier Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382015
- Sponsor's protocol ID
- CL-201
- Other IDs
- 4R44DK107080-02
- Status last verified
- Jan 2018
- First submitted
- 11 Dec 2017
- Last updated
- 10 Aug 2018
- 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 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Evaluate the Effect of BKR-013 on Average Daily Glucose Levels in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT03382015
- Acronym / sponsor ID
- CL-201
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BioKier Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 Dec 2017 (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-013 on average daily glucose (ADG) levels in type 2 diabetes (T2D) subjects during 28 days of either placebo or active test product administration. Subjects will serve as their own controls in this crossover design, and ADG will be compared while a subject is on active test product versus while they received placebo test product.
Detailed description
The study consists of a screening period followed by a 28-day treatment period, a 3 to 5 week washout period, and a second treatment period. All subjects receive both active test product and placebo, but the order in which they receive them (Part 1 or Part 2 of the study) is randomized in this single crossover study. Fourteen subjects will be randomized to ensure that 10 subjects complete both Part 1 and Part 2 of the study.
There are a total of 7 study visits including screening. In Part 1, Visits 2, 3 and 4 occur 2 weeks apart; in Part 2, Visits 5, 6 and 7 also occur 2 weeks apart. Visits 4 and 7 are overnight visits during which time hunger and satiety will be assessed and a Mixed Meal Tolerance Test (MMTT) will be performed after an overnight fast. The MMTT requires use of an indwelling IV catheter so that 11 blood draws can be more comfortably obtained over a period of 4 hours.
Subjects will be required to wear a glucose monitoring sensor during Part 1 and Part 2 of the study in order to obtain ADG levels.
Routine chemistry and hematology tests are done at 4 timepoints during the study. An ECG and physical exam is performed at screening.
A rapid HbA1c will only be tested at screening; if the value is between 6.5% and 10.5%, all other screening procedures will be performed; if the HbA1c value is not within the qualifying range, the subject will be considered a screen failure and no other screening procedures will be performed.
Subjects are required to keep a daily diary to document dosing (twice daily), medication changes and any adverse events.
Safety tests include chemistry/hematology, vital signs and adverse events.
Subjects with type 2 diabetes must be under the care of a healthcare professional to take part in this study. The test product BKR-013 is not designed to treat diabetes; it is being evaluated as a non-prescription medical food for nutritional use in managing glucose levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: BKR-013 or PlaceboReceives 28 days of active test product (BKR-013) in Part 1 of the study and receives 28 days of placebo in Part 2 of the study, following a washout period. |
| Group 2 | Placebo comparator | Other: BKR-013 or PlaceboReceives 28 days of placebo in Part 1 of the study and receives 28 days of active test product (BKR-013) in Part 2 of the study, following a washout period. |
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
- Has given written informed consent to participate in this study
- Agrees to comply with all study requirements, including maintaining current diet and exercise routine and current prescription medications for the duration of the study
Key exclusion criteria (17 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-013 or PlaceboEncapsulated L-glutamine | Other | Group 1, Group 2 |
Primary outcome
Average Daily Glucose Levels
Time frame: After 28 days of treatment in Part 1 and in Part 2
Intra-patient comparison of ADG in Part 1 vs Part 2
2 secondary outcomes
Glucose >180 mg/dL
Time frame: After 28 days of treatment in Part 1 and in Part 2
Triglycerides
Time frame: After 28 days of treatment in Part 1 and in Part 2
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 10 Aug 2018.
- 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 R Szewczyk, PhD study director
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 of Type 2 Diabetes Mellitus, 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 17 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 10 Aug 2018. 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. 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?
Average Daily Glucose Levels (time frame: After 28 days of treatment in Part 1 and in Part 2). 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 10 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.