Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise

• DOI: 10.1111/dom.12325
• Publication Date: 2014-06-06T19:26:37Z
• Authors: K. Kaku; A. Kiyosue; S. Inoue; N. Ueda; T. Tokudome; J. Yang; A. M. Langkilde
• Keywords: Dapagliflozin; Glycated haemoglobin

To evaluate the efficacy and safety of selective sodium glucose co-transporter 2 inhibitor dapagliflozin in Japanese patients with type diabetes mellitus (T2DM) inadequately controlled by diet exercise.Patients received placebo or (5 10 mg) once daily for 24 weeks. The primary outcome measure was change from baseline glycated haemoglobin (HbA1c).Patients (N = 261) had modestly elevated HbA1c (mean ≈ 7.5%) most mild moderate renal impairment (estimated glomerular filtration rate range 43-103 ml/min/1.73 m(2)). Greater reductions mean level were observed mg, -0.41%; -0.45%) than (-0.06%) at week these greater higher levels. Fasting plasma (FPG) also significantly reduced -8.6 mg/dl; -13.7 mg/dl) compared (+5.8 mg/dl). Dapagliflozin body weight -2.13 kg; -2.22 kg) (-0.84 kg). Overall, 47.7 64.8% 5 respectively, 51.7% experienced ≥ 1 adverse event, mostly moderate, unrelated to study treatment. Two on mg reported hypoglycaemia. Four across all groups events suggestive genital infection four urinary tract infection. No pyelonephritis reported.Dapagliflozin well tolerated effective reducing HbA1c, FPG over weeks T2DM exercise.