LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts

Listen Trial Group1,049 enrolled

Overview

The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,049

Conditions

Hypercholesterolemia With Concomitant Type 2 Diabetes

Interventions

AtorvastatinDRUG

Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months. (When not reach the LDL-C level of target in the Japan Atherosclerosis Society \[JAS\] Guidelines \[GL\] after 3 months, had the atorvastatin \[ATV\] dose of 20 mg.)

RosuvastatinDRUG

Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months. (When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin \[RSV\] dose of 10 mg.)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Hypercholesterolemia patients • Patients who have not achieved the target control levels of LDL-C in the "Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007" 2. Type 2 diabetes patients * Patients diagnosed with type 2 diabetes and receiving diet therapy, exercise therapy, or medication * Patients who received constant therapy for three months before registration and have no plan for therapy change * Patients with kept HbA1c level (Japan Diabetes Society \[JDS\] level) of less than 7.0% (or, National Glycohemoglobin Standardization Program \[NGSP\] level of less than 7.4%) within three months before registration * Patients receiving or not receiving medication at present 3. Patients giving voluntary written consent to participate in the study 4. Male or female patients at 20 years or older Exclusion Criteria: 1. Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration 2. Patients with severe hypertension (systolic blood pressure \[SBP\] ≥ 180 mmHg or diastolic blood pressure \[DBP\] ≥ 110 mmHg) 3. Patients with type 1 diabetes 4. Patients judged to have familial hypercholesterolemia 5. Patients with a serum triglyceride level of ≥ 400 mg/dL 6. Patients who had the onset of cardiovascular or cerebrovascular disease within three months 7. Patients with serious heart failure (NYHA classification III - IV) 8. Patients with a history of hypersensitivity to statins 9. Patients with a history of drug-induced myopathy 10. Patients with severe complication of diabetes 11. Patients receiving insulin 12. Patients with serious liver or kidney disease 13. Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan 14. Patients who are or may be pregnant 15. Patients judged by the investigators to be ineligible for participation in the study for any other reason

Locations (133)

Outcomes

Primary Outcomes

Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level

Time frame: Baseline, and 12 months after administration

Change in HbA1c Level

Time frame: Baseline, 12 months after administration

Secondary Outcomes

Occurrence of Deterioration of Diabetic Treatment Status

"Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of \> 0.5%.

Time frame: Baseline, 12 months after administration

Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status

"Deterioration of diabetic treatment status" is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of \> 0.5%.

Time frame: Baseline, 3, 6, 12 months after administration

Percent Change in 1,5-AG Level

An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa

Time frame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

Change in HbA1c Level

Time frame: Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）

Percent Change in Blood Glucose Level (Fasting)

Time frame: Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）

Data from ClinicalTrials.gov

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