A Comparative Study on the Efficacy and Safety of Dose Escalation of Luseogliflozin in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control.

ABSTRACT

Objective In this study, we aimed to assess the safety and efficacy of the dose escalation of luseogliflozin (LUSEO) in type 2 diabetes mellitus (T2DM) patients with poor glycemic control. To that end, we compared two groups assigned to two different doses of luseogliflozin (LUSEO) for 12 weeks. Methods Patients with a hemoglobin A1c (HbA1c) level of 7% or higher already on treatment with luseogliflozin 2.5 mg/day for 12 weeks or longer were randomly assigned to either the 2.5-mg/day group (control group) or the 5-mg/day group (dose-escalation group) of luseogliflozin through the envelope method and were treated for 12 weeks. Blood and urine samples were collected at two different time points at weeks 0 and 12 after randomization. The primary outcome was the change in HbA1c from the baseline to 12 weeks. The secondary outcomes were changes in the body mass index (BMI), body weight (BW), blood pressure (BP), fasting plasma glucose (FPG), lipid parameters, hepatic function, or renal function from the baseline to 12 weeks. Results Based on our findings, HbA1c levels significantly decreased in the dose-escalation group when compared to the control group (p<0.001) at week 12. Conclusion For T2DM patients with poor glycemic control under treatment with LUSEO at a dose of 2.5 mg, dose escalation of LUSEO to 5 mg safely improved glycemic control, and this might prove to be an effective and safe treatment option.