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Fixed-dose Atorvastatin/Fenofibrate vs Atorvastatin Impact on Lipid Profile in Type 2 Diabetes and Dyslipidemia Patients

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Study Aim

This study aims to evaluate the effectiveness of a fixed-dose combination of Atorvastatin/Fenofibrate compared to Atorvastatin alone in improving the lipid profile of patients with Type 2 Diabetes and Dyslipidemia, by observing the reduction in LDL cholesterol levels, changes in lipid profile figures, and the proportion of subjects achieving triglyceride levels below 150 mg/dL.

What is being tested

Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose

+ Atorvastatin (Lipitor ®)

Drug
Who is being recruted

Diabetes Mellitus+7

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 75 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorLaboratorios Silanes S.A. de C.V.
Study ContactJorge A González, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 15, 2022

Actual date on which the first participant was enrolled.

This clinical trial aims to evaluate the effectiveness and safety of a fixed-dose combination of Atorvastatin and Fenofibrate compared to Atorvastatin alone in managing the lipid profile of patients with type 2 diabetes and dyslipidemia. Dyslipidemia is a condition characterized by high levels of triglycerides and LDL (Low-density lipoprotein) cholesterol. This study targets patients who require pharmacological treatment for lipid control, aiming to improve their lipid profile numbers and overall health. The outcomes of this study could potentially enhance the care and treatment of patients with type 2 diabetes and dyslipidemia. Participants in this study will receive either the fixed-dose combination of Atorvastatin and Fenofibrate or Atorvastatin alone. The study will measure the change in lipid profile figures, including LDL cholesterol, Lp(a), and triglycerides, at 2 and 4 months compared to the baseline measurements. Additionally, the study will assess the proportion of subjects who achieve a reduction in LDL cholesterol by more than 30% from their baseline value and those who achieve triglyceride levels below 150 mg/dL at the end of treatment. The study also aims to evaluate the effect on anthropometric, biochemical, and clinical indicators, as well as any adverse reactions that may occur.

Official TitleConfirmatory 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).
NCT04882293
Principal SponsorLaboratorios Silanes S.A. de C.V.
Study ContactJorge A González, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

78 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesHypertriglyceridemiaGlucose Metabolism DisordersDyslipidemiasLipid Metabolism Disorders

Criteria

6 inclusion criteria required to participate
Age 18 to 75 years old.
That the subject agrees to participate in the study and gives their informed consent in writing.
Both genres.
Diagnosis of type 2 diabetes mellitus with adequate glycemic control defined by HbA1c ≤ 7.5% at the time of selection.
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13 exclusion criteria prevent from participating
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).
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Group A: Atorvastatin / Fenofibrate in fixed dose Pharmaceutical Form: Tablets Dosage: 20 mg /160 mg Adminstration way: Oral

Group II

Active Comparator
Group B: Atorvastatin (Lipitor ®) Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Laboratorio Silanes, S.A. de C.V.

Mexico City, MexicoOpen Laboratorio Silanes, S.A. de C.V. in Google Maps
SuspendedOne Study Center