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

Objective: 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. Research design and methods: 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. Results: 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) A_1c) level of 5. 85 ± 0. 37%, and mean low-density lipoprotein cholesterol (LDL-C) level of 129. 8 ± 23. 8 mg/dl at screening. Conclusions: 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.