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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT04882293
Eligibility Criteria:
Inclusion Criteria:
* That the subject agrees to participate in the study and gives their informed consent in writing.
* Both genres.
* Age 18 to 75 years old.
* Diagnosis of type 2 diabetes mellitus with adequate glycemic control defined by HbA1c ≤ 7.5% at the time of selection.
* Diagnosis of dyslipidemia prior to the start of the study (LDL cholesterol\> 100 mg / dl and triglycerides\> 150 mg / dl).
* Willing to avoid sexual contact or to use a barrier method of contraception while conducting the study.
Exclusion Criteria:
* The drug is contraindicated for medical reasons.
* Consumption of oral contraceptives, cyclosporine or strong cytochrome p450 (CYP) 3A4 inhibitors, protease inhibitors, erythromycin and azoles.
* Patients with Type 1 Diabetes Mellitus.
* Acute or Severe renal dysfunction (glomerular filtration \<30 ml / min / 1.72 m2).
* History of chronic liver disease or ALT and / or AST ≥ 2 times the upper limit of normal, or GGT ≥3 times the upper limit of normal.
* Chronic or acute pancreatitis except for acute pancreatitis due to severe hypertriglyceridemia (defined by the presence of triglycerides\> 1000 mg / dl and / or milky plasma, in the absence of other etiological factors of pancreatitis).
* Patients with active gallbladder disease (defined as acute or chronic gallbladder disorders associated with clinical signs or symptoms).
* Patient with a history or presence of myopathies.
* Pregnant or lactating women.
* Known contraindication or hypersensitivity to the use of any of the components of the investigational drug.
* The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
* At the medical discretion, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver or mental failure or with scheduled surgical or hospital procedures.
* Be a patient with a working relationship with the principal investigator or the research center or prisoner.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04882293
Study Brief:
Protocol Section:
NCT04882293