The PREDICTIVE^TM Study: A multinational, prospective observational study to evaluate the safety and efficacy of insulin detemir treatment in patients with type 1 and 2 diabetes-data from the Japan cohort

The PREDICTIVE^TM Study of Japan was an open-label, non-randomized 52-week observational study to evaluate the safety and efficacy of insulin detemir when used in routine clinical practice. Patients with either type 1 or 2 diabetes in whom insulin detemir was to be prescribed but without a previous history of using insulin detemir were eligible to participate. The primary endpoint was an incidence of serious adverse drug reaction (SADR) for the entire observational period. Data were collected at baseline, 12, 26, and 52 weeks. A total of 3,519 patients were enrolled in 540 institutions between 2008 and 2009. Thirty patients (0. 9%) reported 32 SADRs. The rate of total hypoglycemic episodes was 1. 51 episodes/patient-year in patients with type 1 diabetes and 0. 23 episodes/patient-year in patients with type 2 diabetes. The rate of total hypoglycemic episodes did not increase during the observational period. Significant reductions were observed at 52 weeks in HbA1c levels (0. 51% in type 1 diabetes, P < 0. 001; 0. 80% in type 2 diabetes, P < 0. 001), fasting glucose level (reduction of 22. 1 mg/dl in type 1 diabetes, P < 0. 001; 25. 6 mg/dl in type 2 diabetes, P < 0. 001), and intrapatient fasting glucose variability (coefficient of variance; reduction of 11. 4% in type 1 diabetes, P < 0. 001; 4. 1% for type 2 diabetes, P < 0. 001). Our results from the 52-week follow-up data of 3,345 Japanese patients with diabetes demonstrated that insulin detemir contributed to a lower incidence of SADRs (<1%) and suggested that treatment with detemir could provide better glycemic control without increasing hypoglycemic episodes.