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

Primary Purpose

Diabetes Mellitus, Dyslipidemia

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Rosuvastatin

Simvastatin

About this trial

This is an interventional health services research trial for Diabetes Mellitus

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Taichung Veterans General Hospital
Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks

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

Outcomes

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

Secondary Outcome Measures

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

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

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;

Full Information

NCT ID

NCT00506961

First Posted

July 24, 2007

Last Updated

December 5, 2011

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT00506961

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Dyslipidemia

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

10 mg rosuvastatin for 4 weeks followed by 20 m rosuvastatin for another 8 weeks

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

crestor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Other Intervention Name(s)

zocor

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Time Frame

12 weeks

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chii-Min Hwu, MD

Organizational Affiliation

Taipei Veterans General Hospital, Taiwan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wayne H Sheu, MD,phD

Organizational Affiliation

Taichung Veterans General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taichung Veterans General Hospital

City

Taichung

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

35727095

Citation

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.

Results Reference

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

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