Overview

This trial is active, not recruiting.

Condition hypercholesterolemia with concomitant type 2 diabetes
Treatments atorvastatin, rosuvastatin
Sponsor Listen Trial Group
Start date March 2012
End date June 2014
Trial size 1000 participants
Trial identifier NCT01544309, 0059

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
atorvastatin Lipitor
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 JAS GL after 3 months, had the ATV dose of 20 mg.)
(Experimental)
rosuvastatin Crestor
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 RSV dose of 10 mg.)

Primary Outcomes

Measure
Change rate of non-HDL-C level
time frame: 12 months after administration
Amount of change in HbA1c level
time frame: 12 months after administration

Secondary Outcomes

Measure
Occurrence of deterioration of diabetic treatment status
time frame: 3, 6, 12 months after administration
Time to the occurrence of deterioration of diabetic treatment status
time frame: 3, 6, 12 months after administration
Amount of change in HbA1c level
time frame: 3, 6 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status)
Rate and amount of change in 1,5-AG level
time frame: 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status)
Rate and amount of change in blood glucose level (fasting)
time frame: 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status)
Rate and amount of change in insulin level
time frame: 3, 6, 12 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status)
Frequency of cardiovascular events (coronary artery disease, heart failure, cerebrovascular disease, peripheral artery disease and aortic disease)
time frame: From the start of the treatment to the end of study treatment
Frequency and type of (serious) adverse events
time frame: At the start of the treatment, 3, 6, and 12 months after administration
Rates of changes in lipids (LDL-C, HDL-C, TC, TG, non-HDL-C/HDL-C ratio, and FFA)
time frame: 3, 6, 12 months after administration, the end of starting dose and the end of study treatment
Rate of change in non-HDL-C level
time frame: 3 and 6 months after administration, the end of starting dose and the end of study treatment
Rate of change 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) and their correlation
time frame: 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 JASGL2007
time frame: 3 months after administration, the end of starting dose and the end of study treatment

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: 1. Hypercholesterolemia patients • Patients who have not achieved the target control levels of LDL-C in "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 (JDS level) of less than 7.0% (or , 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 (SBP ≥ 180 mmHg or 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

Additional Information

Official title Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Listen Trial Group.