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

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Dyslipidemia
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Simvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Taichung Veterans General Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks	Drug: Rosuvastatin; 10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks; Other Names: crestor
Active Comparator: 2; 20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks	Drug: Simvastatin; 20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks; Other Names: zocor

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Chii-Min Hwu, MD, Taipei Veterans General Hospital, Taiwan; Principal Investigator: Wayne H Sheu, MD,phD, Taichung Veterans General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: July 24, 2007
• First Submitted That Met QC Criteria: July 24, 2007
• First Posted (Estimate): July 25, 2007

Study Record Updates

• Last Update Posted (Estimate): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 5, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Simvastatin
• Other Study ID Numbers: AZ-RSV-RT-01