Clinical trial NCT04673656: Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
Official title: Randomized, Double-Blind, Placebo-Controlled, Dose-Response 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: 2020-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 approximately 15 weeks; the screening period can be up to 3 weeks prior to the start of test period, followed by a 12-week test period. During the test period, subjects will self-administer three tablets of test product, two times daily: before breakfast and before bedtime.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Changes in HOMA-IR
timeFrame: Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84
Secondary outcomes:
measure: Changes in fasting low-density lipoprotein-cholesterol (LDL-C)
timeFrame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
measure: Changes in fasting triglycerides
timeFrame: Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84
measure: Changes in HbA1c
timeFrame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
measure: Changes in fasting glucose
timeFrame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
measure: Changes in fasting insulin
timeFrame: Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Durham
country: United States
facility: Duke Clinical Research at Pickett Road
state: North Carolina
city: Kannapolis
country: United States
facility: Duke Clinical & Translational Science Institute (CTSI)
state: North Carolina
Study officials:
References: