Clinical trial NCT04882293: Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.
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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus
Keywords: Dyslipidemia
Type 2 diabetes
Hypertriglyceridemia
Lipid profile
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Magnitude of change in lipid profile figures.
timeFrame: Baseline, 2 and 4 months.
measure: Proportion of subjects achieving triglyceride levels <150 mg /dL.
timeFrame: 4 months
measure: Describe the proportion of subjects who reduced levels of LDL cholesterol
timeFrame: Baseline and 4 months.
Secondary outcomes:
measure: Impact on anthropometric indicators (Weight)
timeFrame: Baseline and 4 Months
measure: Impact on anthropometric indicators body mass index (BMI)
timeFrame: Baseline and 4 months
measure: Impact on anthropometric indicators (Waist circumference)
timeFrame: Baseline and 4 months
measure: Impact on liver function with aspartate aminotransferas (AST)
timeFrame: Baseline and 4 months
measure: Impact on liver function with Alanine Aminotransferase (ALT)
timeFrame: Baseline and 4 months
measure: Impact on Glycosylated hemoglobin (HbA1c)
timeFrame: Baseline and 4 months
measure: Impact on glucose levels
timeFrame: Baseline and 4 months
measure: Impact on Blood pressure
timeFrame: Baseline and 4 months
measure: Impact on heart rate
timeFrame: Baseline and 4 months
measure: Impact on respiratory rate
timeFrame: Baseline and 4 months
measure: Events and adverse reactions presented.
timeFrame: 4 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
Study officials:
affiliation: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)
name: Alberto J Zamora Muciño-Arroyo, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Resultados médicos, desarrollo e investigación SC (REMEDI)
name: Joel Rodríguez Saldaña, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent
name: Francisco G Padilla Padilla, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)
name: Juan A Peraza Zaldivar, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Hispano S.A de C.V
name: Luis M Román Pintos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Escobedo-de la Pena J, de Jesus-Perez 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.
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.
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.
citation: 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. doi: 10.2337/diacare.25.7.1198.