Status:
UNKNOWN
Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Dyslipidemia Associated With Type II Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profi...
Detailed Description
To assess the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia. Assessing the mag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04882293
Start Date
February 15 2022
End Date
May 1 2022
Last Update
March 2 2022
Active Locations (1)
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1
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico, 11000