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

Listen Trial Group

Status: Completed

Conditions: Hypercholesterolemia With Concomitant Type 2 Diabetes

Treatments: Drug: Rosuvastatin; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01544309

0059

Details and patient eligibility

About

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.

Enrollment: 1,049 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,049 participants in 2 patient groups

Atorvastatin administration group

Experimental group

Treatment:

Drug: Atorvastatin

Rosuvastatin administration group

Experimental group

Treatment:

Drug: Rosuvastatin