NCT04279444

Effects of BKR-017 on Insulin Resistance in Type 2 Diabetes Patients

Open-Label Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters 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-017 on insulin resistance in type 2 diabetes (T2D) subjects during 28 days of active test product administration.

Detailed description

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

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BKR-017	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.

Timeline

• Start date: 2020-06-16
• Primary completion: 2020-11-10
• Completion: 2020-11-15
• First posted: 2020-02-21
• Last updated: 2020-12-04

Locations

1 site across 1 country: United States