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

Last updated: February 28, 2022
Sponsor: Laboratorios Silanes S.A. de C.V.
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT04882293
SIL-30301-III-20(1)
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • That the subject agrees to participate in the study and gives their informed consentin 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 whileconducting the study.

Exclusion

Exclusion Criteria:

  • The drug is contraindicated for medical reasons.
  • Consumption of oral contraceptives, cyclosporine or strong cytochrome p450 (CYP) 3A4inhibitors, 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 ofnormal, or GGT ≥3 times the upper limit of normal.
  • Chronic or acute pancreatitis except for acute pancreatitis due to severehypertriglyceridemia (defined by the presence of triglycerides> 1000 mg / dl and / ormilky plasma, in the absence of other etiological factors of pancreatitis).
  • Patients with active gallbladder disease (defined as acute or chronic gallbladderdisorders 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 theinvestigational drug.
  • The patient is participating in another clinical study involving an investigationaltreatment or participated in one in the previous 4 weeks.
  • At the medical discretion, a disease that affects the prognosis and preventsoutpatient management, for example, but not restricted to: end-stage cancer, kidney,heart, respiratory or liver or mental failure or with scheduled surgical or hospitalprocedures.
  • Be a patient with a working relationship with the principal investigator or theresearch center or prisoner.

Study Design

Total Participants: 78
Study Start date:
February 15, 2022
Estimated Completion Date:
May 31, 2022

Study 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.

Connect with a study center

  • Laboratorio Silanes, S.A. de C.V.

    Mexico City, 11000
    Mexico

    Active - Recruiting

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