N/A
N=1,049
LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts
Hypercholesterolemia With Concomitant Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01544309 ↗Enrolled (actual)
1,049
Serious AEs
3.2%
Results posted
Mar 2015
Primary outcome: Primary: Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level — -31.3; -32.8 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Atorvastatin (Drug); Rosuvastatin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Listen Trial Group
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level |
-31.3; -32.8 | — |
| PRIMARY Change in HbA1c Level |
0.05; 0.00; 0.13; 0.12 | — |
| SECONDARY Occurrence of Deterioration of Diabetic Treatment Status |
64; 45; 177; 162 | — |
| SECONDARY Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status |
20; 14; 12; 8; 32; 23 | — |
| SECONDARY Percent Change in 1,5-AG Level |
-1.6; 5.5; -6.5; 2.6; -3.8; 3.5 | — |
| SECONDARY Change in HbA1c Level |
0.05; 0.00; 0.13; 0.12 | — |
| SECONDARY Percent Change in Blood Glucose Level (Fasting) |
3.3; 2.7; 7.0; 5.9; 4.6; 3.7 | — |
| SECONDARY Change in Blood Glucose Level (Fasting) |
2.6; 0.1; 6.8; 4.3; 3.6; 1.5 | — |
| SECONDARY Percent Change in Insulin Level |
40.7; 31.3; 45.1; 35.5; 17.4; 13.8 | — |
| SECONDARY Change From Baseline in Insulin Level |
-0.10; -0.54; 0.66; -0.44; -1.50; -2.91 | — |
| SECONDARY Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease) |
5; 9 | — |
| SECONDARY Frequency of Serious Adverse Events (SAE) |
14; 19 | — |
| SECONDARY Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA) |
-36.6; -39.2; -35.6; -36.4; -33.2; -34.7 | — |
| SECONDARY Percent Change in Non-HDL-C Level |
-33.8; -35.5; -33.2; -33.5 | — |
| SECONDARY Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation |
— | — |
| SECONDARY Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007 |
89.0; 89.9; 86.3; 87.5 | — |
| SECONDARY Change From Baseline in 1,5-AG Level |
-0.51; -0.21; -1.28; -0.94; -0.88; -1.09 | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT01544309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.