NCT03382015

Effect of BKR-013 on Average Daily Glucose Levels

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: BioKier Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	BKR-013 or Placebo	Encapsulated L-glutamine

Timeline

• Start date: 2018-01-09
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2017-12-22
• Last updated: 2018-08-10

Locations

1 site across 1 country: United States