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

February 28, 2022 updated by: Laboratorios Silanes S.A. de C.V.

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 11000
        • Recruiting
        • Laboratorio Silanes, S.A. de C.V.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alberto J Zamora Muciño-Arroyo, M.D.
        • Principal Investigator:
          • Joel Rodríguez Saldaña, M.D.
        • Principal Investigator:
          • Francisco G Padilla Padilla, M.D.
        • Principal Investigator:
          • Juan A Peraza Zaldicar, M.D.
        • Principal Investigator:
          • Luis M Román Pintos, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A: Atorvastatin / Fenofibrate in fixed dose
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
1 tablet once a day, 20 mg /160 mg, Orally
Other Names:
  • ATV / FENO
Active Comparator: Group B: Atorvastatin (Lipitor ®)
Group B: Atorvastatin (Lipitor ®) Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral
Drug: Atorvastatin (Lipitor ®)
1 tablet once a day, 20 mg, Orally
Other Names:
  • ATV (Lipitor ®)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Magnitude of change in lipid profile figures.
Time Frame: Baseline, 2 and 4 months.
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.
Time Frame: 4 months
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
Time Frame: Baseline and 4 months.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact on anthropometric indicators (Weight)
Time Frame: Baseline and 4 Months
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)
Time Frame: Baseline and 4 months
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)
Time Frame: Baseline and 4 months
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)
Time Frame: Baseline and 4 months
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)
Time Frame: Baseline and 4 months
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)
Time Frame: Baseline and 4 months
Describe the changes in HbA1c percentage from baseline to the end of the study (4 months).
Baseline and 4 months
Impact on glucose levels
Time Frame: Baseline and 4 months
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
Time Frame: Baseline and 4 months
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
Time Frame: Baseline and 4 months
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
Time Frame: Baseline and 4 months
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.
Time Frame: 4 months
Proportion of events and adverse reactions presented during 4 months of treatment.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laboratorios Silanes S.A. de C.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alberto J Zamora Muciño-Arroyo, M.D, Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)
  • Principal Investigator: Joel Rodríguez Saldaña, M.D, Resultados médicos, desarrollo e investigación SC (REMEDI)
  • Principal Investigator: Francisco G Padilla Padilla, M.D, Independent
  • Principal Investigator: Juan A Peraza Zaldivar, M.D, Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)
  • Principal Investigator: Luis M Román Pintos, PhD, Hospital Hispano S.A de C.V

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIL-30301-III-20(1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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