Effects of BKR-017 on Insulin Resistance in Type 2 Diabetes Patients

NCT04279444 | Completed

• 1 other identifier: CL-401
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Insulin resistance (HOMA-IR)

  Changes, Day 0 to Day 28 in patient's insulin resistance (HOMA-IR)

  28 days of active test product administration

Secondary Outcomes (4)

• Fasting glucose

  Day 0 to Day 28

• Fasting insulin

  Day 0 to Day 28

• Fasting triglycerides

  Day 0 to Day 28

• Triglyceride, glucose, and insulin AUCs

  4 hours in the MMTT

Study Arms (1)

Active BKR-017

EXPERIMENTAL

Open label study. All patients will receive 28 days of active treatment.

Dietary Supplement: BKR-017

Interventions

BKR-017 DIETARY_SUPPLEMENT

BioKier, Inc. is developing colon-targeted, oral formulations of natural gut hormone secretagogues as non-prescription medical foods or supplements for nutritional use for improvement of insulin sensitivity.

Active BKR-017

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioKier Inc.: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• George Szewczyk, PhD

  BioKier Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: June 16, 2020
• Primary Completion: November 10, 2020
• Study Completion: November 15, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)