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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Rosuvastatin Calcium; Simvastatin

Criteria

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.