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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: BKR-017

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active BKR-017; Open label study. All patients will receive 28 days of active treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: BioKier Inc.
• Investigators: Study Chair: George Szewczyk, PhD, BioKier Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): November 10, 2020
• Study Completion (Actual): November 15, 2020

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: CL-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No