Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy vs Rosuvastatin Monotherapy in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia

This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.

Inclusion Criteria:

1. Aged 19 to 70 years
2. Patient with type 2 diabetes who needs treatment for hypercholesterolemia
3. Written informed consent

Exclusion Criteria:

1. Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit

2. Uncontrollable diabetes with HbA1c ≥ 8.5%

3. Fasting LDL-C ≤ 70 mg/dL

4. Fasting triglyceride ≥ 400 mg/dL

5. Total cholesterol ≥ 300 mg/dL

6. History of muscular disease or rhabdomyolysis due to use of statin

7. Hypersensitive to rosuvastatin or ezetemibe

8. Contraindications stated in the SPC of rosuvastatin or rosuvastatin/ezetimibe including the following:

   ① Severe renal disease (estimated GFR(MDRD) < 30mL/min/1.73m2)

   ② ALT, AST > 3x ULN or history of active liver disease

   ③ CPK > 3x ULN

9. Administration of other investigational products within 30 days prior to screening visit

10. Other than the above who is deemed to be ineligible to participate in the trial by investigator