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This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (<100 mg/dL) and non-HDL-C (<130 mg/dL).
The duration of patient participation will be 18 weeks consisting of a 1-week screening period, a 5-week lead-in period, followed by a 12-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks |
|
| 2 | Active Comparator | 20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients achieving the combined treatment goal of LDL-C < 100mg/dl and non-HDL-C < 130 mg/dl at week 12 with rosuvastatin treatment compared with simvastatin treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4; | 4 weeks | |
| Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12; | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chii-Min Hwu, MD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Wayne H Sheu, MD,phD | Taichung Veterans General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Taichung | Taiwan | ||||
| Taipei Veterans General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727095 | Derived | Wu TH, Lee IT, Ho LT, Sheu WH, Hwu CM. Combined lipid goal attainment in patients with type 2 diabetes and dyslipidemia: A head-to-head comparative trial of statins. J Chin Med Assoc. 2022 Aug 1;85(8):831-838. doi: 10.1097/JCMA.0000000000000765. Epub 2022 Jun 20. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Simvastatin | Drug | 20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks |
|
|
| Percentage of patients achieving the LDL-C goal of <70 mg/dL at Week;The mean percent change from baseline in lipid profile at week 4 and week 12; | 12 weeks |
| Taipei |
| Taiwan |
| D052439 | Lipid Metabolism Disorders |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |