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

Dyslipidemia Associated With Type II Diabetes Mellitus Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04882293
• Other study ID #: SIL-30301-III-20(1)
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2022
• Est. completion date: May 2022

Study information

• Verified date: February 2022
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: Jorge A González, PhD
• Phone: 5254883785
• Email: jogonzalez[@]silanes.com.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemia Associated With Type II Diabetes Mellitus
• Dyslipidemias

Intervention

Drug:
• Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose
1 tablet once a day, 20 mg /160 mg, Orally
• Atorvastatin (Lipitor ®)
1 tablet once a day, 20 mg, Orally

Locations

Country	Name	City	State
Mexico	Laboratorio Silanes, S.A. de C.V.	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

Athyros VG, Papageorgiou AA, Athyrou VV, Demitriadis DS, Kontopoulos AG. Atorvastatin and micronized fenofibrate alone and in combination in type 2 diabetes with combined hyperlipidemia. Diabetes Care. 2002 Jul;25(7):1198-202. — View Citation

Escobedo-de la Peña J, de Jesús-Pérez R, Schargrodsky H, Champagne B. [Prevalence of dyslipidemias in Mexico city and Its relation to other cardiovascular risk factors. Results from the CARMELA study]. Gac Med Mex. 2014 Mar-Apr;150(2):128-36. Spanish. — View Citation

Harivenkatesh N, David DC, Haribalaji N, Sudhakar MK. Efficacy and safety of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia: a randomized controlled trial. J Cardiovasc Pharmacol Ther. 2014 May;19(3):296-303. doi: 10.1177/1074248413518968. Epub 2014 Feb 10. — View Citation

Lella M, Indira K. A comparative study of efficacy of atorvastatin alone and its combination with fenofibrate on lipid profile in type 2 diabetes mellitus patients with hyperlipidemia. J Adv Pharm Technol Res. 2013 Jul;4(3):166-70. doi: 10.4103/2231-4040.116778. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Events and adverse reactions presented.	Proportion of events and adverse reactions presented during 4 months of treatment.	4 months

External Links

•   NOM. 037-SSA2-2012 para la prevención, tratamiento y control de las dislipidemias. México: Diario Oficial de la Federación. 2012;13.