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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Listen Trial Group
ClinicalTrials.gov Identifier:
NCT01544309
First received: February 23, 2012
Last updated: October 15, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Listen Trial Group:

Primary Outcome Measures:
  • Change rate of non-HDL-C level [ Time Frame: 12 months after administration ] [ Designated as safety issue: No ]
  • Amount of change in HbA1c level [ Time Frame: 12 months after administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of deterioration of diabetic treatment status [ Time Frame: 3, 6, 12 months after administration ] [ Designated as safety issue: Yes ]
  • Time to the occurrence of deterioration of diabetic treatment status [ Time Frame: 3, 6, 12 months after administration ] [ Designated as safety issue: Yes ]
  • 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） ] [ Designated as safety issue: Yes ]
  • 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） ] [ Designated as safety issue: Yes ]
  • 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） ] [ Designated as safety issue: Yes ]
  • 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） ] [ Designated as safety issue: Yes ]
  • 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 and type of (serious) adverse events [ Time Frame: At the start of the treatment, 3, 6, and 12 months after administration ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 2012
Estimated 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 JAS GL after 3 months, had the 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 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 "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
  Contacts and Locations
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

Responsible Party: Listen Trial Group
ClinicalTrials.gov Identifier: NCT01544309     History of Changes
Other Study ID Numbers: 0059
Study First Received: February 23, 2012
Last Updated: October 15, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 19, 2013