Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)

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.

Inclusion criteria

Inclusion criteria

for the screening test (within 6 months before screening):

• LDL-cholesterol 100-159 mg/dl and/or total cholesterol 180-239 mg/dl
• At least one of the following:

• Fasting plasma glucose 100-125 mg/dl, and/or casual (non-fasting) plasma glucose 120-199 mg/dl, and/or HbA1c 5.5-6.0%
• At least two of the following risk factors for impaired glucose tolerance:

• Second degree relative with diabetes
• BMI >= 24 kg/m2
• Systolic blood pressure >=130 mmHg, and/or diastolic blood pressure >= 85 mmHg, and/or receiving treatment for hypertension
• Triglyceride >= 150 mg/dl, and/or HDL < 40 mg/dl
• Written consent for participation in the study by their own volition after being provided sufficient explanation for the participation into this clinical trial

Inclusion criteria

for the entry (Confirmed by screening test):

-Impaired glucose tolerance by 75g oral glucose tolerance test (fasting plasma glucose <126 mg/dl and 2-h plasma glucose 140-199 mg/dl)

Exclusion criteria

• History of diabetes (except gestational diabetes)
• Fasting plasma glucose >= 126 mg/dl , and/or 2-h plasma glucose >= 200 mg/dl
• HbA1c >= 6.5%
• Diabetic retinopathy
• Receiving with hormone replacement therapy
• Pancreatic diseases ( e.g. pancreatitis, pancreatectomy, pancreatic cancer), Endocrine diseases ( e.g. Cushing's syndrome, acromegaly, pheochromocytoma, aldosteronism, hyperthyroidism )
• Receiving statins, fibrates or anion exchange resins
• Cancer or suspected cancer
• History of gastrectomy
• History of myocardial infarction, angina, or heart failure (NYHA Class >= III)
• Severe hypertension (SBP >= 180 mmHg or DBP >= 110 mmHg)
• Renal disease, including serum creatinine >= 2.0 mg/dl
• Hepatic disease, including transaminase (ALT or AST) >= 2 times the upper limit of normal
• Women hoping to become pregnant during the intended study period
• Contraindication or relative contraindication of Livalo® Tab(pitavastatin calcium)

• History of hypersensitivity to any of the ingredients of the product
• Severe hepatic disorder or biliary atresia
• Receiving cyclosporine
• Pregnant women, women suspected of being pregnant, or lactating women
• Patients receiving fibrates who also have laboratory evidence of abnormal renal function
• Familial hypercholesterolemia
• Drug abuse, alcoholism
• Individuals who are ineligible in the opinion of the investigator