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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04279444
Study type	Interventional
Source	BioKier Inc.
Contact
Status	Completed
Phase	N/A
Start date	June 16, 2020
Completion date	November 15, 2020

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