Status:
COMPLETED
Effects of BKR-017 on Insulin Resistance in Type 2 Diabetes Patients
Lead Sponsor:
BioKier Inc.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
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 screeni...
Eligibility Criteria
Inclusion
- Males and females between the ages of 18 and 70 years at the time of screening, inclusive
- Diagnosed with T2D and under the care of a healthcare professional for its management
- HbA1c 6.5-10.5%, inclusive
- HOMA-IR 2.7 and above
- Has given written informed consent to participate in this study
- Willing to complete 28-day test period, including two overnight stays
- Willing to maintain current diet and exercise routine and current prescription medications for the duration of the study
Exclusion
- Type 1 diabetes
- History of bariatric or intestinal surgery
- 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
- Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
- 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
- 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
- Uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
- Active significant infection as determined by the investigator
- Known allergy to butyrate or any of the components of the tablets
- 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)
- Allergy or intolerance to Boost® High Protein drink
- Pregnant, nursing, or trying to become pregnant
- Presence of pitting edema on physical exam
- High fiber diet
- 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.
- Subject is taking one or more of the excluded therapies. See list of excluded therapies in section 4.4.
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04279444
Start Date
June 16 2020
End Date
November 15 2020
Last Update
December 4 2020
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808