Combination of Rosuvastatin and Ezetimibe to improve Postprandial Triglyceride and Glucose in Patients with Diabetes Mellitus or Metabolic Syndrome
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0003198
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Combination therapy with ezetimibe plus rosuvastatin significantly lowered post-prandial TG and LDL cholesterol compared with rosuvastatin monotherapy in patients with type 2 diabetes mellitus. Addition of ezetimibe may have effects beyond lowering LDL cholesterol. In conclusion, 12-week treatment with ezetimibe 10mg plus rosuvastatin 10mg was more effective in lowering postprandial TG and LDL cholesterol than was rosuvastatin 10mg in patients with type 2 diabetes. Combination therapy was also associated with favorable results in insulin resistance. The results of the current study could help better understand the mechanism behind beneficial effects of ezetimibe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
1) Patients over age of 20 and with a LDL-cholesterol = 100mg/dL, who are not taking medication for dyslipidmeia in the 4 weeks prior to randomization.
2) Patient with either type 2 diabetes mellitus or metabolic syndrome
(1) Type 2 diabetes mellitus
- on oral hypoglycemic agents
- newly diagnosed patients (HbA1c =6.5%, fasting bloos glucose =126mg/dL, PP2 =200mg/dL on post-prandial testing, or random glucose = 200mg/dL with specific symptoms of diabetes)
(2) Metabolic syndrome
- meeting 3 of the below criteria, accoring to NCEP ATP III guidelines modified to Korean standards
? Waist circumference >90 cm in men, >85 cm in women
? Triglycerides 150 mg/dL or greater
? HDL-cholesterol <40 mg/dL in men and <50 mg/dL in women
? BP 130/85 mmHg or greater, or on treatment for hypertension
? Fasting glucose 110 mg/dL or greater, or on treatment for diabetes
(1) Hypersensitivity to the study drug or its substance
(2) Active liver disease, or AST/ALT levels over 5 times the upper limit of normal
(3) Myopathy or serum CK levels over 5 times the upper limit of normal
(4) Cyclosporine use
(5) Moderate+ kidney dysfunction (creatinine clearance, CLcr <30mL/min)
(6) Pregnancy or breasfeeeding
(7) Alcoholic
(8) Medications that may influence the lipid profile:
- fibrate, bile acid sequestrants, niacin, drugs for management of obesity, systemic steroids, fish oil, fiber-based laxatives, phytosterol margarines, etc.
- medications that influence thyroid function (medications for thyroid replacement therapies are allowed)
(9) Other reasons that the investigator deems to be unfit for enrollment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change(%) in post-prandial TG
- Secondary Outcome Measures
Name Time Method Absolute change in post-prandial TG;Absolute change and percentage change in post-prandial glucose;Absolute change and percentage change in TG/HDL ratio;Absolute change and percentage change in post-prandial Apo-B;Change in insulin sensitivity;Absolute change and percentage change in C-reactive protein;Percentage of patients reaching LDL-C target goal according to NCEP ATP III risk