A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia

Study Overview
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Brief Summary
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A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.

Detailed Description
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This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.

Official Title
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A Multicenter Clinical Trial to Compare the Efficacy and Safety Between Rosuvastatin/Ezetimibe Combination and Monotherapy of Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia

Conditions
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Diabetes Mellitus and Hypercholesterolemia

Intervention / Treatment
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* Drug: Rosuvastatin+Ezetimibe
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥ 19 or ≤ 75 years of age Subjects undergoing treatment for type 2 diabetes Subjects undergoing treatment of statin for hypercholesterolemia Fasting LDL-C ≤ 250mg/dL at the screening visit Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit Fasting TG<500mg/dL Exclusion Criteria: Subjects with hypersensitivity reaction to Statin and Ezetimibe Subjects with severe kidney disease Subjects with HIV positive result at the screening Pregnant or breast-feeding subjects Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.) Insulin-treated Subjects Other exclusions applied

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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: Rosuvastatin+Ezetimibe<br>Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week | Drug: Rosuvastatin+Ezetimibe<br>* Rosuvastatin 5mg+Ezetimibe 10mg<br>* Other names: Rosuvamibe ® 10/5mg;|
| Active Comparator: Rosuvastatin<br>Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week | Drug: Rosuvastatin<br>* Rosuvastatin 5Mg Tablet<br>* Other names: Monorova ® 5mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoprotein cholesterol (LDL-C) (%) | The rate of change(%) of LDL-C at Week 8 compared to the baseline | baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoprotein cholesterol (LDL-C) (100mg/dL) | The ratio of patients who reached the treatment target (100mg/dL) of LDL-C at Week 8 compared to the baseline | baseline, Week 8 | 
| HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) | Variation of HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) at Week 8 compared to the baseline resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) change form the baseline at Week 8 | baseline, Week 8 | 
| LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) | Variation of LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) at Week 8 compared to the baseline Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) change form the base line at Week 8 | baseline, Week 8 | 
| Thiobarbituric acid reactive substances(TBARs) | Absolute value change of Thiobarbituric acid reactive substances(TBARs) at Week 8 compared to baseline to baseline. | baseline, Week 8 | 
| Fibroblast Growth Factor 21 | Absolute value change of Fibroblast Growth Factor 21 at Week 8 compared to baseline. | baseline, Week 8 |