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).
试验速览
- 阶段
- 3 期
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Magnitude of change in lipid profile figures.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose (Drug)
Group B: Atorvastatin (Lipitor ®)
Group B: Atorvastatin (Lipitor ®) Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral
干预措施: Atorvastatin (Lipitor ®) (Drug)
结局指标
主要结局
Magnitude of change in lipid profile figures.
时间窗: 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.
时间窗: 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
时间窗: Baseline and 4 months.
Describe the proportion of subjects who reduced levels of LDL cholesterol, under 30% compare to the baseline value.
次要结局
- Impact on anthropometric indicators (Weight)(Baseline and 4 Months)
- Impact on anthropometric indicators body mass index (BMI)(Baseline and 4 months)
- Impact on anthropometric indicators (Waist circumference)(Baseline and 4 months)
- Impact on liver function with aspartate aminotransferas (AST)(Baseline and 4 months)
- Impact on liver function with Alanine Aminotransferase (ALT)(Baseline and 4 months)
- Impact on Glycosylated hemoglobin (HbA1c)(Baseline and 4 months)
- Impact on glucose levels(Baseline and 4 months)
- Impact on Blood pressure(Baseline and 4 months)
- Impact on heart rate(Baseline and 4 months)
- Impact on respiratory rate(Baseline and 4 months)
- Events and adverse reactions presented.(4 months)