Type 2 Diabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBKR-017
Nutrient butyrate into a colon-targeted tablet formulation (BKR-017) is intended to stimulate secretion of GLP-1 from L-cells in the lower gut. Butyrate delivered to the colon in tablet form will not cause the side-effects seen with formation of butyrate by fermentation.
Sponsors
BioKier Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HOMA-IR | Baseline, Day 1, during the treatment period at days 21, 42, and 63, and at end of treatment period, Day 84 | Changes in HOMA-IR at Days 21, 42, 63, and 84 using repeated measures ANCOVA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fasting low-density lipoprotein-cholesterol (LDL-C) | Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 | Changes in fasting low-density lipoprotein-cholesterol (LDL-C) at Days 1, 42, and 84 |
| Changes in fasting triglycerides | Baseline, Day 1, during the treatment period at days 42, and at end of treatment period, Day 84 | Changes in fasting triglycerides at Days 1, 42, and 84 |
| Changes in HbA1c | Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 | Changes in HbA1c at Days 1, 42, and 84 |
| Changes in fasting glucose | Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 | Changes in fasting glucose at Days 1, 42, and 84 |
| Changes in fasting insulin | Baseline, Day 1, during the treatment period at day 42, and at end of treatment period, Day 84 | Changes in fasting insulin at Days 1, 42, and 84 |
Countries
United States
Outcome results
None listed