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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvamibe® Tab | Experimental | Rosuvamibe® Tab (rosuvastatin 5mg/ezetimibe 10mg) qd for 8 weeks |
|
| Monorova® Tab | Active Comparator | Monorova® Tab (rosuvastatin 10mg) qd for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvamibe® Tab | Drug | Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 8 in ApoB/ApoA1 ratio | Baseline, Week 8 |
| 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 |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Kora-ri | South Korea | ||||
| Asan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32065359 | Derived | Lee J, Hwang YC, Lee WJ, Won JC, Song KH, Park CY, Ahn KJ, Park JY. Comparison of the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy on Lipoprotein in Patients With Type 2 Diabetes: Multicenter Randomized Controlled Study. Diabetes Ther. 2020 Apr;11(4):859-871. doi: 10.1007/s13300-020-00778-1. Epub 2020 Feb 17. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Monorova® Tab |
| Drug |
Rosuvastatin 10mg qd for 8 weeks |
|
| 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 |
| Seoul |
| 05505 |
| South Korea |
| D004700 | Endocrine System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |