Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Dyslipidemia

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female between the ages of 20-75 years. Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control. Diagnosed with type 2 diabetes mellitus. Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no change in the category of anti-diabetic agents, but the dose is adjustable). All patients give written informed consent. Exclusion Criteria: A history of hypersensitivity to statins. A history of rhabdomyolysis or hereditary muscle disorders. Insulin-treated patients. Patient with any conditions of acute or chronic pancreatitis. Creatine kinase ≧3-fold upper limit of normal (ULN). Patients with an estimated creatinine clearance (see note)≦30 ml/min or bilirubin ≧1.5-fold ULN, or chronic active hepatitis or liver function impairment (AST and ALT ≧3-fold ULN). Overt proteinuria (repeat spot urine protein >300mg/dl by dipstick method). Patients are taking cyclosporine. A history of homozygous familial hypercholesterolemia or familial dysbetalipoproteinemia. Patients with alcohol and drug abuse in past 3 years. Serious or unstable medical or psychological conditions. Hypothyroidism (TSH > 5 μIU/mL). In the investigator's opinion, continuation in the study would be detrimental to the patient's well-being or might confound the clinical trial.

Ages Eligible for Study
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Minimum Age: 20 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks | Drug: Rosuvastatin<br>* 10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks<br>* Other names: crestor;|
| Active Comparator: 2<br>20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks | Drug: Simvastatin<br>* 20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks<br>* Other names: zocor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |