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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Hypercholesterolemia

Intervention / Treatment
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* Drug: Rosuvamibe® Tab
* Drug: Monorova® Tab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 19 to 70 years Patient with type 2 diabetes who needs treatment for hypercholesterolemia Written informed consent Exclusion Criteria: Administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit Uncontrollable diabetes with HbA1c ≥ 8.5% Fasting LDL-C ≤ 70 mg/dL Fasting triglyceride ≥ 400 mg/dL Total cholesterol ≥ 300 mg/dL History of muscular disease or rhabdomyolysis due to use of statin Hypersensitive to rosuvastatin or ezetemibe 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 Administration of other investigational products within 30 days prior to screening visit Other than the above who is deemed to be ineligible to participate in the trial by investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvamibe® Tab<br>Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks | Drug: Rosuvamibe® Tab<br>* Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks<br>|
| Active Comparator: Monorova® Tab<br>Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks | Drug: Monorova® Tab<br>* Rosuvastatin 10mg qd for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 8 in ApoB/ApoA1 ratio |  | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of over 50% reduction in LDL-C |  | Baseline, Week 8 | 
| Proportion of subjects achieving the comprehensive lipid target (LDL-C<70mg/dL, Non-HDL-C<100mg/dL, and ApoB<80mg/dL) |  | Baseline, Week 8 | 
| Change from baseline to week 8 in total, non-HDL, LDL and HDL cholesterol, triglyceride, ApoB, ApoA1 and ApoB48 |  | Baseline, Week 8 | 
| Change from baseline to week 8 in HOMA-IR |  | Baseline, Week 8 | 
| Change from baseline to week 8 in hs-CRP |  | Baseline, Week 8 | 
| Change from baseline to week 8 in HbA1C |  | Baseline, Week 8 | 
| Change from baseline to week 8 in FPG |  | Baseline, Week 8 |