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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

78

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Laboratorios Silanes S.A. de C.V.

Investigators

  • 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)

February 15, 2022

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Dyslipidemia Associated With Type II Diabetes Mellitus

Clinical Trials on Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe