Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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 profile of patients with type 2 diabetes and dyslipidemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Atorvastatin; Fenofibrate

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.