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Effect of BKR-013 on Average Daily Glucose Levels

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BKR-013 or Placebo
Sponsored by
BioKier Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females between the ages of 18 and 70 years at the time of screening, inclusive
  2. Diagnosed with T2D and under the care of a healthcare professional for its management
  3. HbA1c 6.5-10.5%, inclusive
  4. Has given written informed consent to participate in this study
  5. Agrees to comply with all study requirements, including maintaining current diet and exercise routine and current prescription medications for the duration of the study
  6. Willing to wear a Continuous Glucose Monitoring (CGM) sensor continuously for 28 days during each of the two test periods
  7. 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.

Exclusion Criteria:

  1. Type 1 diabetes
  2. History of bariatric or intestinal surgery
  3. 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
  4. Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
  5. 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
  6. 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
  7. Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
  8. Active significant infection as determined by the investigator
  9. Known allergy to L-glutamine or any of the components of the capsules
  10. 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)
  11. Allergy or intolerance to Boost® High Protein drink
  12. 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.
  13. Pregnant, nursing, or trying to become pregnant
  14. Presence of pitting edema on physical exam
  15. High fiber diet
  16. 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.
  17. Subject is taking one or more of the excluded therapies.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Average Daily Glucose Levels
Intra-patient comparison of ADG in Part 1 vs Part 2

Secondary Outcome Measures

Glucose >180 mg/dL
Percent of each 24-hour period that a subject's glucose is >180 mg/dL
Triglycerides
Differences in fasting triglycerides between active test product and placebo

Full Information

First Posted
December 11, 2017
Last Updated
August 9, 2018
Sponsor
BioKier Inc.
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03382015
Brief Title
Effect of BKR-013 on Average Daily Glucose Levels
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioKier Inc.
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
BKR-013 or Placebo
Intervention Description
Encapsulated L-glutamine
Primary Outcome Measure Information:
Title
Average Daily Glucose Levels
Description
Intra-patient comparison of ADG in Part 1 vs Part 2
Time Frame
After 28 days of treatment in Part 1 and in Part 2
Secondary Outcome Measure Information:
Title
Glucose >180 mg/dL
Description
Percent of each 24-hour period that a subject's glucose is >180 mg/dL
Time Frame
After 28 days of treatment in Part 1 and in Part 2
Title
Triglycerides
Description
Differences in fasting triglycerides between active test product and placebo
Time Frame
After 28 days of treatment in Part 1 and in Part 2

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 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. 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, 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George R Szewczyk, PhD
Organizational Affiliation
BioKier Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of BKR-013 on Average Daily Glucose Levels

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