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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT00506961
First received: July 24, 2007
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus
Dyslipidemia
Drug: Rosuvastatin
Drug: Simvastatin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12; [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: June 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: zocor

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506961

Locations
Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: vghtpe user, Attending physician, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT00506961     History of Changes
Other Study ID Numbers: AZ-RSV-RT-01
Study First Received: July 24, 2007
Last Updated: December 5, 2011
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Simvastatin
Rosuvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014