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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
1 tablet once a day, 20 mg /160 mg, Orally
1 tablet once a day, 20 mg, Orally
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico
RECRUITINGMagnitude of change in lipid profile figures.
To assess the magnitude of change in lipid profile figures (Lp \[a\], LDL, and triglycerides) at 2 and 4 months with respect to their baseline measurement and between treatment groups.
Time frame: Baseline, 2 and 4 months.
Proportion of subjects achieving triglyceride levels <150 mg /dL.
Describe the proportion of subjects who achieved triglyceride levels \<150 mg / dL at the end of treatment.
Time frame: 4 months
Describe the proportion of subjects who reduced levels of LDL cholesterol
Describe the proportion of subjects who reduced levels of LDL cholesterol, under 30% compare to the baseline value.
Time frame: Baseline and 4 months.
Impact on anthropometric indicators (Weight)
Describe changes in weight (kg) measurements from baseline to the end of the study (4 months).
Time frame: Baseline and 4 Months
Impact on anthropometric indicators body mass index (BMI)
Describe changes in BMI (kg/m2) from baseline to the end of the study (4 months)
Time frame: Baseline and 4 months
Impact on anthropometric indicators (Waist circumference)
Describe changes in waist circumference (cm) from baseline to the end of the study (4 months).
Time frame: Baseline and 4 months
Impact on liver function with aspartate aminotransferas (AST)
Describe the changes in AST (mg/dL) concentration, between baseline and the end of the study.
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Time frame: Baseline and 4 months
Impact on liver function with Alanine Aminotransferase (ALT)
Describe the changes in ALT (mg/dL) concentration, between baseline and the end of the study.
Time frame: Baseline and 4 months
Impact on Glycosylated hemoglobin (HbA1c)
Describe the changes in HbA1c percentage from baseline to the end of the study (4 months).
Time frame: Baseline and 4 months
Impact on glucose levels
Describe the changes in glucose levels (mg/dL) from baseline to the end of the study (4 months).
Time frame: Baseline and 4 months
Impact on Blood pressure
Describe the changes in blood pressure (mm Hg) from baseline to the end of the study (4 months). impact on clinical indicators (Blood pressure, Heart rate, Respiratory rate).
Time frame: Baseline and 4 months
Impact on heart rate
Describe the changes in heart rate (beats per minute) from baseline to the end of the study (4 months).
Time frame: Baseline and 4 months
Impact on respiratory rate
Describe the changes in respiratory rate (Pulses per minute) from baseline to the end of the study (4 months).
Time frame: Baseline and 4 months
Events and adverse reactions presented.
Proportion of events and adverse reactions presented during 4 months of treatment.
Time frame: 4 months