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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active BKR-017 | Experimental | Open label study. All patients will receive 28 days of active treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BKR-017 | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance (HOMA-IR) | Changes, Day 0 to Day 28 in patient's insulin resistance (HOMA-IR) | 28 days of active test product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose | Changes in fasting glucose | Day 0 to Day 28 |
| Fasting insulin | Changes in fasting insulin | Day 0 to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Szewczyk, PhD | BioKier Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 27, 2023 | |
| Reset | Apr 18, 2024 | |
| Release | May 17, 2024 | |
| Unrelease | May 21, 2024 | |
| Release | Aug 8, 2024 | |
| Reset | Oct 25, 2024 | |
| Release | Oct 30, 2024 | |
| Unrelease | Oct 30, 2024 | |
| Release | Nov 4, 2024 | |
| Reset | Dec 19, 2024 | |
| Release | Feb 10, 2025 | |
| Reset | Feb 28, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 27, 2023 | Apr 18, 2024 | |||
| May 17, 2024 | May 21, 2024 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Fasting triglycerides | Changes in fasting triglycerides | Day 0 to Day 28 |
| Triglyceride, glucose, and insulin AUCs | Changes in triglyceride, glucose, and insulin AUCs | 4 hours in the MMTT |
| Aug 8, 2024 | Oct 25, 2024 |
| Oct 30, 2024 | Oct 30, 2024 |
| Nov 4, 2024 | Dec 19, 2024 |
| Feb 10, 2025 | Feb 28, 2025 |
| D004700 | Endocrine System Diseases |