Diabetes Mellitus, Dyslipidemia
Conditions
Brief summary
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
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.
Interventions
DRUGRosuvastatin
10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks
DRUGSimvastatin
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female between the ages of 20-75 years. 2. Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control. 3. Diagnosed with type 2 diabetes mellitus. 4. Fasting triglyceride ≧150 mg/dL ≦500 mg/dL or Non-HDL-C≧130,but≦200 mg/dL 5. Patients receiving stable antidiabetic treatment for 8 weeks before randomization (no change in the category of anti-diabetic agents, but the dose is adjustable). 6. All patients give written informed consent.
Exclusion criteria
1. A history of hypersensitivity to statins. 2. A history of rhabdomyolysis or hereditary muscle disorders. 3. Insulin-treated patients. 4. Patient with any conditions of acute or chronic pancreatitis. 5. Creatine kinase ≧3-fold upper limit of normal (ULN). 6. 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). 7. Overt proteinuria (repeat spot urine protein \>300mg/dl by dipstick method). 8. Patients are taking cyclosporine. 9. A history of homozygous familial hypercholesterolemia or familial dysbetalipoproteinemia. 10. Patients with alcohol and drug abuse in past 3 years. 11. Serious or unstable medical or psychological conditions. 12. Hypothyroidism (TSH \> 5 μIU/mL). 13. In the investigator's opinion, continuation in the study would be detrimental to the patient's well-being or might confound the clinical trial.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Taiwan
Outcome results
None listed