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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin 10/20mg vs atorvastatin 20mg treatment.
DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout or TLC period. Primary and secondary endpoints will be assessed at week 12.
Primary endpoint:
1) change of ApoB/ApoA ratio at week 12.
Secondary endpoint:
Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.
Change of HbA1C at week 12.
Change of HOMA index at week 12
- HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5
Change of hsCRP at week 12
Safety assessment
Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simvastatin/ezetimibe (vytorin) group | Experimental | vytorin 10/20mg po once daily for 12weeks |
|
| atorvastatin group | Active Comparator | atorvastatin 20mg po once daily for 12weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simvastatin/ezetimibe | Drug | simvastatin/ezetimibe 10/20mg once daily for 12weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of ApoB/ApoA1 | change of ApoB/ApoA1 | after 12 weeks' treatment |
| Measure | Description | Time Frame |
|---|---|---|
| change of lipid profile | change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48 | 12weeks |
| change of HbA1c | change of HbA1c |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun-Jae Kang | Contact | 82-2-2072-2279 | nowkang@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university hospital | Seoul | 110744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23728830 | Derived | Lee JH, Kang HJ, Kim HS, Sohn DW, Oh BH, Park YB. Effects of ezetimibe/simvastatin 10/20 mg vs. atorvastatin 20 mg on apolipoprotein B/apolipoprotein A1 in Korean patients with type 2 diabetes mellitus: results of a randomized controlled trial. Am J Cardiovasc Drugs. 2013 Oct;13(5):343-51. doi: 10.1007/s40256-013-0031-6. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 25, 2011 | |
| Unrelease | Yes | |
| Release | Nov 22, 2011 |
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| atorvastatin 20mg | Drug | atorvastatin 20mg once daily for 12weeks |
|
| 12weeks |
| change of HOMA index | HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5 | 12weeks |
| change of hsCRP | change of hsCRP | 12weeks |
| safety | CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms | during 12weeks of treatment |
| Reset | Dec 23, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 25, 2011 | Yes | |||
| Nov 22, 2011 | Dec 23, 2011 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000069438 | Ezetimibe |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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