Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance (the J-PREDICT study): rationale, study design, and clinical characteristics of 1269 patients

Abstract

The Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance (J-PREDICT study) is an open-label randomized controlled study in a population with impaired glucose tolerance (IGT) to evaluate the effect of the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) pitavastatin on new onset of diabetes. Patients with IGT by World Health Organization (WHO) criteria [2-h plasma glucose ≥140 and <200 mg/dl and fasting plasma glucose (FPG) <126 mg/dl] were randomly assigned in a 1:1 ratio to either the control group receiving lifestyle modification or the pitavastatin group receiving pitavastatin 1–2 mg/day in addition to lifestyle modification. The primary endpoint is cumulative incidence of diabetes based on the 75-g oral glucose tolerance test (OGTT). This study will be completed in March 2015. A total of 1269 patients enrolled at 149 study sites in Japan were randomly assigned to two groups. The characteristics of these participants were: men 62.4%, age ≥60 years 40.8%, body mass index (BMI) ≥25 kg/m2 48.3%, concomitant hypertension 44.5%, and 2-h plasma glucose ≥170 mg/dl 36.6%. This population had a mean FPG level of 104.2 ± 10.7 mg/dl, mean 2-h plasma glucose level of 163.6 ± 17.0 mg/dl, mean hemoglobin (Hb) A1c) level of 5.85 ± 0.37%, and mean low-density lipoprotein cholesterol (LDL-C) level of 129.8 ± 23.8 mg/dl at screening. The J-PREDICT study is a world first to evaluate the effect of a statin on the onset of diabetes as the primary endpoint and will providing useful information regarding the controversial effect of statins on new-onset of diabetes.