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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT03377335
Eligibility Criteria:
Inclusion Criteria:
* men and women with T2DM;
* age \>18;
* BMI ≥20 kg/m\^2;
* HbA1c 7.0-9.0 %;
* receiving metformin therapy at least 1500 mg/day for at least 8 weeks before screening;
* plasma triglycerides \<400 mg/dL, plasma LDL-cholesterol \< 250 mg/dL;
* stabile daily dose(s) of hypolipidemic drugs (statins, ezetimibe) for at least 7 weeks prior to the day of randomization;
* adequately controlled blood pressure (≤140/90 mmHg) to be maintained during the study according to Standard of Care;
* able to swallow whole tablets.
Exclusion Criteria:
* pregnancy or willingness to became pregnant;
* severe liver dysfunction (alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 times upper limit of normal);
* renal failure with glomerular filtration rate (eGFR) \<60 ml/min/1.73m\^2;
* major cardiovascular event (myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack) within 12 weeks before screening;
* severe infections (such as HIV and HCV);
* any malignancy within 5 years before screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03377335
Study Brief:
Protocol Section:
NCT03377335