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:	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:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

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
1: Active Comparator 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
2: Active Comparator 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

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
Taipei Veterans General Hospital
Taipei, Taiwan
Taichung Veterans General Hospital
Taichung, 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:	Taipei Veterans General Hospital ( Low-Tone Ho/Professor and Head of Department )
Study ID Numbers:	AZ-RSV-RT-01
Study First Received:	July 24, 2007
Last Updated:	June 22, 2009
ClinicalTrials.gov Identifier:	NCT00506961 History of Changes
Health Authority:	Taiwan: Department of Health

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010