The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes in a population with impaired glucose tolerance.
Diabetes mellitus and its complications are major health problems globally. People with impaired glucose tolerance (IGT) are at high risk of developing diabetes. It is therefore important to focus on preventing diabetes in individuals with IGT. HMG-CoA reductase inhibitors (statins) are widely used for hypercholesterolemia, one of the most frequent metabolic disorders. However, there is no direct evidence to whether statins are beneficial for preventing diabetes. This study is designed to compare the efficacy of life-style modification versus life-style modification with pitavastatin (a statin) administration, in individuals with IGT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,240
As the life-style interventions aiming to reduce the major risks of developing diabetes mellitus, instruct the following four items:(1)set diet right, (2)maintain normal weight,(3)improve physical activity,(4)normalize smoking and alcohol drinking.
Once-daily dosing of pitavastatin 1 mg(1 tablet of Livalo Tab 1 mg), or 2mg(2 tablets of Livalo Tab 1mg or 1 tablet of Livalo Tab 2mg);Dosing period of pitavastatin should be 60 months.(max.84 months).
The University of Tokyo, Graduate School of Medicine
Bunkyo-ku, Tokyo, Japan
Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels
Time frame: from April, 2006 to end of March, 2012
Incidence of newly developed diabetes
Time frame: from April, 2006 to end of March, 2012
Cumulative incidence of diabetes based on clinical diagnosis.
Cumulative incidence of diabetes based on clinical diagnosis defined as at least one of the following:(1) Typical symptoms of diabet plus 1 positive OGTT or fasting glucose levels, (2)HbA1c\>=6.5% plus 1 positive OGTT or fasting glucose levels, (3)2 positive OGTT or fasting glucose levels.
Time frame: from April, 2006 to end of March, 2012
Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels
Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels (from the first administration of the study drug after the randomization)
Time frame: from April, 2006 to end of March, 2012
Time until development of diabetes; Improvement in glucose tolerance
Time frame: from April, 2006 to end of March, 2012
Incidence of any cardiovascular disease (myocardial infarction, angina, congestive heart disease, coronary revascularization, cerebral hemorrhage, cerebral infarction.
Time frame: from April, 2006 to end of March, 2012
Incidence of coronary heart disease (myocardial infarction, angina, coronary revascularization)
Time frame: from April, 2006 to end of March, 2012
Incidence of coronary heart disease plus cerebral infarction
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Time frame: from April, 2006 to end of March, 2012
LDL-cholesterol
Time frame: from April, 2006 to end of March, 2012
HDL-cholesterol
Time frame: from April, 2006 to end of March, 2012
Triglyceride
Time frame: from April, 2006 to end of March, 2012
RLP-cholesterol
Time frame: from April, 2006 to end of March, 2012
Adiponectin
Time frame: from April, 2006 to end of March, 2012
High sensitive CRP
Time frame: from April, 2006 to end of March, 2012
Asymmetrical dimethyl arginine (ADMA)
Time frame: from April, 2006 to end of March, 2012
Urinary 8-OHd
Time frame: from April, 2006 to end of March, 2012
Fasting plasma glucose
Time frame: from April, 2006 to end of March, 2012
2-h plasma glucose during 75g oral glucose tolerance test
Time frame: from April, 2006 to end of March, 2012
HbA1c
Time frame: from April, 2006 to end of March, 2012
Insulin
Time frame: from April, 2006 to end of March, 2012
HOMA-R
Time frame: from April, 2006 to end of March, 2012
HOMA-β
Time frame: from April, 2006 to end of March, 2012
Insulinogenic index
Time frame: from April, 2006 to end of March, 2012
Time until dropout
Time frame: from April, 2006 to end of March, 2012
Number of adverse events
Time frame: from April, 2006 to end of March, 2012