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

Sponsor:	Taipei Veterans General Hospital,Taiwan
Information provided by (Responsible Party):	vghtpe user, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:	NCT00506961

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 IV

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

Drug Information available for: Simvastatin Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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:

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.

Contacts and Locations

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 February 09, 2012