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Completed

NCT Number: NCT04673656

Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BKR-017

Dietary Supplement

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.

Other names: Butyrate

Primary outcomes

  1. Changes in HOMA-IR

    Time frame: 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 outcomes

  1. Changes in fasting low-density lipoprotein-cholesterol (LDL-C)

    Time frame: 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

  2. Changes in fasting triglycerides

    Time frame: 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

  3. Changes in HbA1c

    Time frame: 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

  4. Changes in fasting glucose

    Time frame: 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

  5. Changes in fasting insulin

    Time frame: 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

Sponsors and collaborators

Lead sponsor

BioKier Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 17, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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