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Completed

NCT Number: NCT01544309

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

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.

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Key information

Conditions

Hypercholesterolemia With Concomitant Type 2 Diabetes

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hiramitsu Heart Clinic, Nagoya, Aichi Pref., Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

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 names: Lipitor

Rosuvastatin

Drug

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 names: Crestor

Primary outcomes

  1. Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level

    Time frame: Baseline, and 12 months after administration

  2. Change in HbA1c Level

    Time frame: Baseline, 12 months after administration

Secondary outcomes

  1. Occurrence of Deterioration of Diabetic Treatment Status

    Time frame: 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%.

  2. Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status

    Time frame: 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%.

  3. 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）

    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

  4. 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）

  5. 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）

  6. 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）

  7. 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）

    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.

  8. 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）

    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

  9. 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

  10. Frequency of Serious Adverse Events (SAE)

    Time frame: Up to 12 months

  11. 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

  12. 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

  13. 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

    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)

  14. 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

    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.

  15. 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）

    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

Sponsors and collaborators

Lead sponsor

Listen Trial Group

Other

Registry information

Official study title

Study on Effect of Highly Potent Statins on Lipid Lowering Effect and Glucose Metabolism in Hypercholesterolemia Patients With Diabetes Mellitus

Acronym: LISTEN

Important dates

Study start
2012
Primary completion
2014
First posted
Mar 5, 2012
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.