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

Not Applicable

Completed

• Conditions: Hypercholesterolemia With Concomitant Type 2 Diabetes
• Interventions: Drug: Rosuvastatin; Drug: Atorvastatin

• Registration Number: NCT01544309
• Lead Sponsor: Listen Trial Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Study Start: 2012-03
• Study First Posted: 2012-03-05
• Primary Completion: 2014-06
• Results First Submitted: 2014-11-10
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-04
• Last Update Submitted: 2015-03-04
• Results First Posted: 2015-03-17
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1049

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin administration group	Rosuvastatin	-
Atorvastatin administration group	Atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level	Baseline, and 12 months after administration
Change in HbA1c Level	Baseline, 12 months after administration

Secondary Outcome Measures

Name	Time	Method
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）	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.
Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status	Baseline, 3, 6, 12 months after administration	"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%.
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）	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
Occurrence of Deterioration of Diabetic Treatment Status	Baseline, 12 months after administration	"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%.
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
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
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	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)
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	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.
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）	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
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）	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
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

Trial Locations

Locations (133)

Hiramitsu Heart Clinic; 🇯🇵 Nagoya city, Aichi pref., Japan

Honjo Daiichi Hospital; 🇯🇵 Yurihonjo city, Akita pref., Japan

Iryouhoujin Syadan Yanagisawakai Yanagisawa Iin; 🇯🇵 Matsudo city, Chiba pref., Japan

Matsuno Medical Clinic; 🇯🇵 Iyo gun, Ehime pref., Japan

Ishite Matsumoto Naika Junkanki Clinic; 🇯🇵 Matsuyama city, Ehime pref., Japan

Ehime Medical CO OP Izumigawa Clinic; 🇯🇵 Niihama city, Ehime pref., Japan

Fukui Chuoh Clinic; 🇯🇵 Fukui city, Fukui pref., Japan

Fukuoka City Medical Association Hospital; 🇯🇵 Fukuoka city, Fukuoka pref., Japan

Matsumoto Clinic; 🇯🇵 Fukuoka city, Fukuoka pref., Japan

Saku Hospital; 🇯🇵 Fukuoka city, Fukuoka pref., Japan

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