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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Listen Trial Group
ClinicalTrials.gov Identifier:
NCT01544309
First received: February 23, 2012
Last updated: March 4, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Hypercholesterolemia With Concomitant Type 2 Diabetes
Drug: Atorvastatin
Drug: Rosuvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Listen Trial Group:

Primary Outcome Measures:
  • Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level [ Time Frame: Baseline, and 12 months after administration ] [ Designated as safety issue: No ]
  • Change in HbA1c Level [ Time Frame: Baseline, 12 months after administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of Deterioration of Diabetic Treatment Status [ Time Frame: Baseline, 12 months after administration ] [ Designated as safety issue: Yes ]
    "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%.

  • Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status [ Time Frame: Baseline, 3, 6, 12 months after administration ] [ Designated as safety issue: Yes ]
    "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 [ Time Frame: Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status) ] [ Designated as safety issue: Yes ]
    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

  • Change in HbA1c Level [ Time Frame: Baseline, 3, 6 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status) ] [ Designated as safety issue: Yes ]
  • Percent Change in Blood Glucose Level (Fasting) [ Time Frame: Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status) ] [ Designated as safety issue: Yes ]
  • Change in Blood Glucose Level (Fasting) [ Time Frame: Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status) ] [ Designated as safety issue: Yes ]
  • Percent Change in Insulin Level [ Time Frame: Baseline, 3, 6, 12 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status) ] [ Designated as safety issue: Yes ]
    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 Insulin Level [ Time Frame: Baseline, 3, 6, 12 months after administration and the end of study treatment (or at the occurrence of deterioration of diabetic treatment status) ] [ Designated as safety issue: Yes ]
    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

  • 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 ] [ Designated as safety issue: Yes ]
  • Frequency of Serious Adverse Events (SAE) [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA) [ Time Frame: Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment ] [ Designated as safety issue: No ]
  • Percent Change in Non-HDL-C Level [ Time Frame: Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment ] [ Designated as safety issue: No ]
  • Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation [ Time Frame: Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after administration, the end of starting dose and the end of study treatment ] [ Designated as safety issue: No ]
    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 From Baseline in 1,5-AG Level [ Time Frame: Baseline, 3, 6, 12 months after administration and the end of study treatment(or at the occurrence of deterioration of diabetic treatment status) ] [ Designated as safety issue: Yes ]
    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


Enrollment: 1049
Study Start Date: March 2012
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin administration group Drug: Atorvastatin

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 the Japan Atherosclerosis Society [JAS] Guidelines [GL] after 3 months, had the atorvastatin [ATV] dose of 20 mg.)

Other Name: Lipitor
Experimental: Rosuvastatin administration group Drug: Rosuvastatin

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 rosuvastatin [RSV] dose of 10 mg.)

Other Name: Crestor

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544309

  Show 133 Study Locations
Sponsors and Collaborators
Listen Trial Group
Investigators
Study Chair: Hisao Ogawa, Ph.D Department of Cardiovascular Medicine, Faculty of Life Sciences, Kumamoto University
  More Information

No publications provided by Listen Trial Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Listen Trial Group
ClinicalTrials.gov Identifier: NCT01544309     History of Changes
Other Study ID Numbers: 0059
Study First Received: February 23, 2012
Results First Received: November 10, 2014
Last Updated: March 4, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hypercholesterolemia
Diabetes Mellitus
Dyslipidemias
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015