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

Dyslipidemia Associated With Type II Diabetes Mellitus Clinical Trial

Official title: Confirmatory Study of the Efficacy and Safety of the Fixed-dose Combination Atorvastatin / Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients With Type 2 Diabetes (T2D) and Dyslipidaemia (DLP).

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 magnitude of change in lipid profile numbers. And describing the effect on anthropometric, biochemical and clinical indicators, as well as events and adverse reactions that may occur. In patients diagnosed with type 2 diabetes and dyslipidemia (triglycerides> 150 mg / dl, LDL (Low density lipoprotein) cholesterol> 100 mg / dl) and who require pharmacological treatment for lipid control. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemia Associated With Type II Diabetes Mellitus
• Dyslipidemias

• NCT number: NCT04882293
• Study type: Interventional
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: Jorge A González, PhD
• Phone: 5254883785
• Email: jogonzalez@silanes.com.mx
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2022
• Completion date: May 2022