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

NCT ID: NCT00506961

Last Updated: 2011-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-07-31

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.

Conditions

Diabetes Mellitus; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

1

10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks

2

20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks

Group Type: ACTIVE_COMPARATOR

Simvastatin

Intervention Type: DRUG

20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks

Interventions

Rosuvastatin

10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks

Intervention Type: DRUG

Simvastatin

20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks

Intervention Type: DRUG

Other Intervention Names

crestor; zocor

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

vghtpe user

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chii-Min Hwu, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Wayne H Sheu, MD,phD

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Locations

Taichung Veterans General Hospital

Taichung, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Wu TH, Lee IT, Ho LT, Sheu WH, Hwu CM. Combined lipid goal attainment in patients with type 2 diabetes and dyslipidemia: A head-to-head comparative trial of statins. J Chin Med Assoc. 2022 Aug 1;85(8):831-838. doi: 10.1097/JCMA.0000000000000765. Epub 2022 Jun 20.

Reference Type: DERIVED

PMID: 35727095 (View on PubMed)

Other Identifiers

AZ-RSV-RT-01

Identifier Type: -

Identifier Source: org_study_id