Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Magnitude of change in lipid profile figures. [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.
- Proportion of subjects achieving triglyceride levels <150 mg /dL. [4 months]
Describe the proportion of subjects who achieved triglyceride levels <150 mg / dL at the end of treatment.
- Describe the proportion of subjects who reduced levels of LDL cholesterol [Baseline and 4 months.]
Describe the proportion of subjects who reduced levels of LDL cholesterol, under 30% compare to the baseline value.
Secondary Outcome Measures
- Impact on anthropometric indicators (Weight) [Baseline and 4 Months]
Describe changes in weight (kg) measurements from baseline to the end of the study (4 months).
- Impact on anthropometric indicators body mass index (BMI) [Baseline and 4 months]
Describe changes in BMI (kg/m2) from baseline to the end of the study (4 months)
- Impact on anthropometric indicators (Waist circumference) [Baseline and 4 months]
Describe changes in waist circumference (cm) from baseline to the end of the study (4 months).
- Impact on liver function with aspartate aminotransferas (AST) [Baseline and 4 months]
Describe the changes in AST (mg/dL) concentration, between baseline and the end of the study.
- Impact on liver function with Alanine Aminotransferase (ALT) [Baseline and 4 months]
Describe the changes in ALT (mg/dL) concentration, between baseline and the end of the study.
- Impact on Glycosylated hemoglobin (HbA1c) [Baseline and 4 months]
Describe the changes in HbA1c percentage from baseline to the end of the study (4 months).
- Impact on glucose levels [Baseline and 4 months]
Describe the changes in glucose levels (mg/dL) from baseline to the end of the study (4 months).
- Impact on Blood pressure [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).
- Impact on heart rate [Baseline and 4 months]
Describe the changes in heart rate (beats per minute) from baseline to the end of the study (4 months).
- Impact on respiratory rate [Baseline and 4 months]
Describe the changes in respiratory rate (Pulses per minute) from baseline to the end of the study (4 months).
- Events and adverse reactions presented. [4 months]
Proportion of events and adverse reactions presented during 4 months of treatment.
Eligibility Criteria
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.
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Patients with Type 1 Diabetes Mellitus.
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Acute or Severe renal dysfunction (glomerular filtration <30 ml / min / 1.72 m2).
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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).
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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.
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Pregnant or lactating women.
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Known contraindication or hypersensitivity to the use of any of the components of the investigational drug.
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The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laboratorio Silanes, S.A. de C.V. | Mexico City | Mexico | 11000 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- SIL-30301-III-20(1)