Title
LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts
Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus
Phase
N/ALead Sponsor
Listen Trial GroupStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hypercholesterolemia With Concomitant Type 2 DiabetesIntervention/Treatment
rosuvastatin atorvastatin ...Study Participants
1049The 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.
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.)
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.)
Inclusion Criteria: 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" 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 Patients giving voluntary written consent to participate in the study Male or female patients at 20 years or older Exclusion Criteria: Patients who administered rosuvastatin, atorvastatin or ezetimibe within three month at the registration Patients with severe hypertension (systolic blood pressure [SBP] ≥ 180 mmHg or diastolic blood pressure [DBP] ≥ 110 mmHg) Patients with type 1 diabetes Patients judged to have familial hypercholesterolemia Patients with a serum triglyceride level of ≥ 400 mg/dL Patients who had the onset of cardiovascular or cerebrovascular disease within three months Patients with serious heart failure (NYHA classification III - IV) Patients with a history of hypersensitivity to statins Patients with a history of drug-induced myopathy Patients with severe complication of diabetes Patients receiving insulin Patients with serious liver or kidney disease Patients with serious concurrent disease such as malignancy, or patients with severely limited lifespan Patients who are or may be pregnant Patients judged by the investigators to be ineligible for participation in the study for any other reason
| Event Type | Organ System | Event Term | Atorvastatin Administration Group | Rosuvastatin Administration Group |
|---|
"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%.
"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%.
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
An inverse relationship exists between mean change in insulin 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.
An inverse relationship exists between mean change in insulin 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
Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP)
Outcome Measure Data Not Reported
Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented.
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
