Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia

A Randomized, Open Label, Dose Titration Study to Evaluate the Efficacy and Safety of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia

A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia

To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .

Inclusion Criteria:

• Age: 25yrs~75yrs
• Fasting TG <400mg/dL, LDL-C ≥130mg/dL
• 3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%

Exclusion Criteria:

• Type1 DM, Gestational diabetes
• Patient need to treat with Insulin
• Patient with operational treatment for severe diabetic complication
• Uncontrolled Hypothyroidism
• Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
• Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
• Renal disorder (Serum creatinine ≥ 2.0mg/dL)
• Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
• Creatinine Kinase > 2.5 X UNL
• Gravida or lactation phase
• Administration of Atorvastatin, Rosuvastatin, Pitavastatin