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
Overview
- Phase
- Phase 4
- Intervention
- Rosuvastatin
- Conditions
- Diabetes Mellitus
- Sponsor
- Taipei Veterans General Hospital, Taiwan
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
vghtpe user
Attending physician
Taipei Veterans General Hospital, Taiwan
Eligibility Criteria
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.
Arms & Interventions
1
10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks
Intervention: Rosuvastatin
2
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks
Intervention: Simvastatin
Outcomes
Primary Outcomes
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
Time Frame: 12 weeks
Secondary Outcomes
- 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)