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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
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.
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Insulin resistance (HOMA-IR)
Changes, Day 0 to Day 28 in patient's insulin resistance (HOMA-IR)
Time frame: 28 days of active test product administration
Fasting glucose
Changes in fasting glucose
Time frame: Day 0 to Day 28
Fasting insulin
Changes in fasting insulin
Time frame: Day 0 to Day 28
Fasting triglycerides
Changes in fasting triglycerides
Time frame: Day 0 to Day 28
Triglyceride, glucose, and insulin AUCs
Changes in triglyceride, glucose, and insulin AUCs
Time frame: 4 hours in the MMTT
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