Clinical trial NCT00506961: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Dyslipidemia
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2007-07-25
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: Achieving the combined treatment goal of LDL-C (<100 mg/dL) and non-HDL-C (130 mg/dL) at week 4;
timeFrame: 4 weeks
measure: Percentage of patients achieving the LDL-C goal of <100 mg/dL at week 4 and week 12;
timeFrame: 12 weeks
measure: 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;
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chii-Min Hwu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taichung Veterans General Hospital
name: Wayne H Sheu, MD,phD
role: PRINCIPAL_INVESTIGATOR
References:
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.