Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT04673656
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04673656
Study Brief:
Protocol Section:
NCT04673656