Effect of BKR-013 on Average Daily Glucose Levels
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|ClinicalTrials.gov Identifier: NCT03382015|
Recruitment Status : Completed
First Posted : December 22, 2017
Last Update Posted : August 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Other: BKR-013 or Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||January 9, 2018|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||June 30, 2018|
Active Comparator: Group 1
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.
Other: BKR-013 or Placebo
Placebo Comparator: Group 2
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.
Other: BKR-013 or Placebo
- 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
- Glucose >180 mg/dL [ Time Frame: After 28 days of treatment in Part 1 and in Part 2 ]Percent of each 24-hour period that a subject's glucose is >180 mg/dL
- Triglycerides [ Time Frame: After 28 days of treatment in Part 1 and in Part 2 ]Differences in fasting triglycerides between active test product and placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382015
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Study Director:||George R Szewczyk, PhD||BioKier Inc.|