Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus

Listen Trial Group133 sites in 1 country1,049 target enrollmentMarch 2012

ConditionsHypercholesterolemia With Concomitant Type 2 Diabetes

InterventionsAtorvastatin Rosuvastatin

DrugsAtorvastatin Rosuvastatin

Overview

Phase: Not Applicable
Intervention: Atorvastatin
Conditions: Hypercholesterolemia With Concomitant Type 2 Diabetes
Sponsor: Listen Trial Group
Enrollment: 1049
Locations: 133
Primary Endpoint: Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

June 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Listen Trial Group

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Atorvastatin administration group

Intervention: Atorvastatin

Rosuvastatin administration group

Intervention: Rosuvastatin

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

Change in HbA1c Level(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 Insulin Level(Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）)
Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status(Baseline, 3, 6, 12 months after administration)
Percent Change in 1,5-AG Level(Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）)
Percent Change in Non-HDL-C Level(Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment)
Occurrence of Deterioration of Diabetic Treatment Status(Baseline, 12 months after administration)
Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)(Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment)
Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)(From the start of the treatment to the end of study treatment)
Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation(Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment)
Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007(3 months after administration, the end of starting dose and the end of study treatment)
Change in Blood Glucose Level (Fasting)(Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）)
Change From Baseline in Insulin Level(Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）)
Change From Baseline in 1,5-AG Level(Baseline, 3, 6, 12 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)(Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）)
Frequency of Serious Adverse Events (SAE)(Up to 12 months)