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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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).

Conditions
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Dyslipidemia Associated With Type II Diabetes Mellitus

Intervention / Treatment
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* Drug: Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose
* Drug: Atorvastatin (Lipitor ®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Atorvastatin / Fenofibrate in fixed dose<br>Group A: Atorvastatin / Fenofibrate in fixed dose Pharmaceutical Form: Tablets Dosage: 20 mg /160 mg Adminstration way: Oral | Drug: Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose<br>* 1 tablet once a day, 20 mg /160 mg, Orally<br>* Other names: ATV / FENO;|
| Active Comparator: Group B: Atorvastatin (Lipitor ®)<br>Group B: Atorvastatin (Lipitor ®) Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral | Drug: Atorvastatin (Lipitor ®)<br>* 1 tablet once a day, 20 mg, Orally<br>* Other names: ATV (Lipitor ®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude 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. | 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. | 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. | Baseline and 4 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on anthropometric indicators (Weight) | Describe changes in weight (kg) measurements from baseline to the end of the study (4 months). | 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) | 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). | 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. | 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. | 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). | 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). | 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). | 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). | 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). | Baseline and 4 months | 
| Events and adverse reactions presented. | Proportion of events and adverse reactions presented during 4 months of treatment. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Type 2 diabetes, Hypertriglyceridemia, Lipid profile