Status:
COMPLETED
Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
Lead Sponsor:
BioKier Inc.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is a randomized, double-blind, placebo-controlled, dose-response study of BKR-017 and placebo that will be conducted at two investigative sites. The total duration of subject involvement is...
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, or newly diagnosed (as participant in the study) with T2D
- HbA1c 6.5% -10.5%, inclusive
- Has given written informed consent to participate in this study
- Willing to complete 84-day test period
- 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
- Active and clinically significant hepatic, pancreatic disease, or renal disease as determined by the investigator
- History of heart 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
- Untreated or 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
- Subjects planning to make major changes to diet and physical activity during the trial duration
- 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)
- Pregnant, nursing, or trying to become pregnant
- 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.
Key Trial Info
Start Date :
April 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04673656
Start Date
April 18 2021
End Date
February 7 2023
Last Update
February 8 2023
Active Locations (3)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
2
Duke Clinical Research at Pickett Road
Durham, North Carolina, United States, 27705
3
Duke Clinical & Translational Science Institute (CTSI)
Kannapolis, North Carolina, United States, 28081