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NCT Number: NCT00506961

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

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Key information

Conditions

Diabetes Mellitus Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taichung Veterans General Hospital, Taichung, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Serious or unstable medical or psychological conditions.
  • Hypothyroidism (TSH > 5 μIU/mL).
  • In the investigator's opinion, continuation in the study would be detrimental to the patient's well-being or might confound the clinical trial.

Treatment and study plan

Rosuvastatin

Drug

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

Other names: crestor

simvastatin

Drug

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

Other names: zocor

Primary outcomes

  1. 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

  1. Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;

    Time frame: 4 weeks

  2. Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;

    Time frame: 12 weeks

  3. 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;

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 25, 2007
Registry last updated
Dec 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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