Ipragliflozin, an SGLT2 Inhibitor, Reduces Body Weight and Fat Mass, but not Muscle Mass, in Japanese Type 2 Diabetic Patients Treated with Insulin: A Randomized Clinical Trial.

AIMS/INTRODUCTION: SGLT2 inhibitors reduce body weight (BW) by creating a negative energy balance. Previous reports have suggested that this BW reduction is mainly loss of body fat and that ~20% of the reduction is lean mass. However, the effects of SGLT2 inhibitors on BW and body composition remain unclear. We examined these effects in Japanese patients with type 2 diabetes mellitus treated with insulin.

MATERIALS AND METHODS: In this open-label, randomized controlled trial, 49 overweight patients (BMI ≥23 kg/m2 ) with inadequate glycemic control (HbA1c >7.0%) on insulin treatment were randomly assigned to receive add-on ipragliflozin (Ipra group) or no additional treatment (Control group). Patients were followed for 24 weeks. The goal in all patients was to achieve HbA1c <7.0% without hypoglycemia. The primary endpoint was change in BW from baseline to week 24. Body composition was assessed with dual energy X-ray absorptiometry and bioelectrical impedance analysis.

RESULTS: BW change was significantly larger in the Ipra group than in the Control group (-2.78 vs. -0.22 kg, P <0.0001). Total fat mass was reduced evenly in the arms, lower limbs and trunk in the Ipra group. Total muscle mass and bone mineral content were maintained, but muscle mass in the arms may have been affected by ipragliflozin treatment.

CONCLUSION: Ipragliflozin treatment for 24 weeks resulted in reduced BW, mainly from fat mass loss. Muscle mass and bone mineral content were maintained. Further study is necessary to elucidate long-term effects of ipragliflozin. This article is protected by copyright. All rights reserved.