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

Completed · Not applicable

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT04279444

Run by

BioKier Inc.

People needed

14

Starts

2020-06-16

Expected to finish

2020-11-15

Last updated by the study team

2020-12-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.
• Subject is taking one or more of the excluded therapies. See list of excluded therapies in section 4.4.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.