Clinical trial NCT04279444: Effects of BKR-017 on Insulin Resistance in Type 2 Diabetes Patients
Official title: Open-Label Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: BioKier Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Insulin resistance (HOMA-IR)
timeFrame: 28 days of active test product administration
Secondary outcomes:
measure: Fasting glucose
timeFrame: Day 0 to Day 28
measure: Fasting insulin
timeFrame: Day 0 to Day 28
measure: Fasting triglycerides
timeFrame: Day 0 to Day 28
measure: Triglyceride, glucose, and insulin AUCs
timeFrame: 4 hours in the MMTT
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: BioKier Inc.
name: George Szewczyk, PhD
role: STUDY_CHAIR
References: