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

Type 2 Diabetes Clinical Trial

Official title:

Open-Label Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279444
• Other study ID #: CL-401
• Status: Completed
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: December 2020
• Source: BioKier Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 15, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Males and females between the ages of 18 and 70 years at the time of screening, inclusive

2. Diagnosed with T2D and under the care of a healthcare professional for its management

3. HbA1c 6.5-10.5%, inclusive

4. HOMA-IR 2.7 and above

5. Has given written informed consent to participate in this study

6. Willing to complete 28-day test period, including two overnight stays

7. Willing to maintain current diet and exercise routine and current prescription medications for the duration of the study

Exclusion Criteria:

1. Type 1 diabetes

2. History of bariatric or intestinal surgery

3. Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis, or chronic/frequent diarrhea or chronic/frequent constipation

4. Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator

5. History of significant heart disease, including congestive heart failure, prior MI, chronic atrial or ventricular fibrillation, coronary artery disease, cerebral vascular disease or other cardiovascular disease, that in the opinion of the investigator should exclude the subject from the study

6. Severely uncontrolled hypertension at screening defined as a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg on the average of two seated measurements after being at rest for at least 5 minutes

7. Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease

8. Active significant infection as determined by the investigator

9. Known allergy to butyrate or any of the components of the tablets

10. Participation in a clinical trial and/or treatment with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)

11. Allergy or intolerance to Boost® High Protein drink

12. Pregnant, nursing, or trying to become pregnant

13. Presence of pitting edema on physical exam

14. High fiber diet

15. In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.

16. Subject is taking one or more of the excluded therapies. See list of excluded therapies in section 4.4.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
BioKier Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance (HOMA-IR)	Changes, Day 0 to Day 28 in patient's insulin resistance (HOMA-IR)	28 days of active test product administration
Secondary	Fasting glucose	Changes in fasting glucose	Day 0 to Day 28
Secondary	Fasting insulin	Changes in fasting insulin	Day 0 to Day 28
Secondary	Fasting triglycerides	Changes in fasting triglycerides	Day 0 to Day 28
Secondary	Triglyceride, glucose, and insulin AUCs	Changes in triglyceride, glucose, and insulin AUCs	4 hours in the MMTT