Efficacy and Safety of Long-Term Administration of Dapagliflozin for Japanese Patients with Type 2 Diabetes Mellitus

Background: There have been few studies yet on the efficacy and safety of SGLT2 inhibitor in Japanese people at 2 years and later. In this study, we administered dapagliflozin to Japanese patients with type 2 diabetes mellitus (DM) and studied its many effects and its safety.

Subjects and Methods: The subjects were 112 patients aged 20 years and older who were administered 5 mg/day of dapagliflozin after outpatient treatment with dapagliflozin between April 2014 and December 2015 at this hospital had been judged as useful by the primary physician. Body weight (BW), systolic blood pressure (sBP), HbA1c, liver enzymes, HDL-cholesterol (HDL-C), and uric acid (UA) were measured during hospital visits, and these values were analyzed by comparing them between before administration and at 104 weeks of administration. Inbody® was used in 44 patients to compare body composition before and after treatment.

Results: Dapagliflozin was administered over a period of 104 weeks, and a significant decrease in HbA1c, from 8.5±1.4% to 7.6±1.4% (week 0 vs. week 104, p<0.001), and a significant decrease in BW, from 82.2±19.3 kg to 78.6±18.9 kg (week 0 vs. week 104, p<0.001), were observed. sBP, UA, and liver enzymes also significantly decreased, and HDL-C significantly increased. When changes in body composition were checked with Inbody®, muscle mass and the amount of fat had both significantly decreased, but because of the large decrease in the amount of fat, the skeletal muscle index significantly increased. Also, the amount of the reduction in fat was significantly correlated with the amount of the decrease in HbA1c. Serious adverse drug reactions were not observed.

Conclusion: Dapagliflozin can be safely administered over a period of 104 weeks to Japanese patients with type 2 DM, and effects such as lower blood sugar, reduced body weight, and improved metabolism can be expected. Also, a reduction in the amount of fat was suggested to be related to a reduction in HbA1c.