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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT02791867
Eligibility Criteria:
Inclusion Criteria:
* Age ≥21 years
* Diagnosis of T2DM
* Metformin as first line treatment
* HbA1c ≥7
* Calculated HOMA-IR ≥3.0,
* BMI 25-45
* Triglyceride level ≥ 2.26 mmol/L
Exclusion Criteria:
* Age \<21 years of age
* BMI ≤ 25
* Pregnant
* Subjects on chronic nonsteroidal anti-inflammatory drugs or systemic corticosteroids.
* Subjects treated with Liraglutide (Victoza®).
* Renal, hepatic or cardiac failure.
* Subjects with a significant clinical illness within a month before the first administration of Aphoeline Brake™
* Subjects diagnosed with Irritable Bowel Syndrome.
* Subjects diagnosed with Ulcerative Colitis or Crohn's disease.
* History of significant gastrointestinal disease.
* Poor venous access.
* Poor likelihood to adhere with study procedures, as documented during the MyFitnessPal procedures prior to use of Aphoeline Brake™
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02791867
Study Brief:
Protocol Section:
NCT02791867