Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia
Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia
This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration
 study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with
 type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with
 simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is
 superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and
 non-HDL-C (<130 mg/dL).
The duration of patient participation will be 18 weeks consisting of a 1-week screening
 period, a 5-week lead-in period, followed by a 12-week treatment period.
Inclusion Criteria:

 1. Male and female between the ages of 20-75 years.

 2. Female patients post menopausal, hysterectomized or if of childbearing potential using
 a reliable method of birth control.

 3. Diagnosed with type 2 diabetes mellitus.

 4. Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL

 5. Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no
 change in the category of anti-diabetic agents, but the dose is adjustable).

 6. All patients give written informed consent.

 Exclusion Criteria:

 1. A history of hypersensitivity to statins.

 2. A history of rhabdomyolysis or hereditary muscle disorders.

 3. Insulin-treated patients.

 4. Patient with any conditions of acute or chronic pancreatitis.

 5. Creatine kinase ≧3-fold upper limit of normal (ULN).

 6. Patients with an estimated creatinine clearance (see note)≦30 ml/min or bilirubin
 ≧1.5-fold ULN, or chronic active hepatitis or liver function impairment (AST and ALT
 ≧3-fold ULN).

 7. Overt proteinuria (repeat spot urine protein >300mg/dl by dipstick method).

 8. Patients are taking cyclosporine.

 9. A history of homozygous familial hypercholesterolemia or familial
 dysbetalipoproteinemia.

 10. Patients with alcohol and drug abuse in past 3 years.

 11. Serious or unstable medical or psychological conditions.

 12. Hypothyroidism (TSH > 5 μIU/mL).

 13. In the investigator's opinion, continuation in the study would be detrimental to the
 patient's well-being or might confound the clinical trial.