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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506961
• Other study ID #: AZ-RSV-RT-01
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2007
• Last updated: December 5, 2011
• Start date: June 2006
• Est. completion date: July 2007

Study information

• Verified date: December 2011
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Rosuvastatin
10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks
• Simvastatin
20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;		4 weeks	No
Secondary	Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;		12 weeks	No
Secondary	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	No