A Prospective Intervention Study on the Efficacy and Safety of Ipragliflozin in Japanese Patients With Type 2 Diabetes in Kanagawa

Abstract

In this study, Ipragliflozin (IP) 50 mg was administered once a day for 52 weeks to Japanese patients with type 2 diabetes mellitus. Of the 458 enrolled patients, 451 were included in the safety analysis, and 376 were included in the efficacy analysis. Glycated hemoglobin, serum lipids, liver enzymes, blood pressure, and body composition were estimated and analyzed by multiple comparisons. The changes at week 52 were −0.9 % for glycated hemoglobin, −2.8 kg for body weight, −1.8 kg for body fat mass, and −1.0 kg for lean mass (p<0.001). Furthermore, significant improvements were observed in the liver enzyme levels, serum lipid levels (high-density lipoprotein-cholesterol and triglyceride), and blood pressure, whereas no significant change was exhibited in the pulse rate. Adverse events were noted in 120/451 patients (26.6 %), the most common being vulvovaginal candidiasis. Treatment with IP demonstrated improvements in the glycemic control and liver function and also reduced the body weight and body fat. IP appeared to exert a minimal impact on the hemodynamics, as evidenced by no significant change in the pulse rate despite a decrease in the blood pressure. Thus, IP can be considered an efficacious and safe drug.