Quality-of-Life Comparison of Dapagliflozin Versus Dipeptidyl Peptidase 4 Inhibitors in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (J-BOND Study)

Hitoshi Ishii; Hiroki Nakajima; Nozomu Kamei; Tetsuji Niiya; Toru Hiyoshi; Yuko Hiramori; Shigeyuki Ohtsu; Takashi Noto; Dai Shimono

doi:10.1007/s13300-020-00941-8

Quality-of-Life Comparison of Dapagliflozin Versus Dipeptidyl Peptidase 4 Inhibitors in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (J-BOND Study)

Diabetes Ther. 2020 Dec;11(12):2959-2977. doi: 10.1007/s13300-020-00941-8. Epub 2020 Oct 15.

Authors

Hitoshi Ishii¹, Hiroki Nakajima², Nozomu Kamei³, Tetsuji Niiya⁴, Toru Hiyoshi⁵, Yuko Hiramori⁶, Shigeyuki Ohtsu⁷, Takashi Noto⁸, Dai Shimono⁹

Affiliations

¹ Department of Doctor-Patient Relationships, Nara Medical University, Kashihara, Nara, Japan. hit3910@gmail.com.
² Department of Diabetes and Endocrinology, Nara Medical University, Kashihara, Nara, Japan.
³ Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima, Hiroshima, Japan.
⁴ Matsuyama Shimin Hospital, Matsuyama, Ehime, Japan.
⁵ Division of Diabetes and Endocrinology, Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan.
⁶ Suzuran-Naika Clinic of Medicine, Nara, Nara, Japan.
⁷ Nakanoshima Diabetes Clinic, Kawasaki, Kanagawa, Japan.
⁸ Nishiyamato Diabetes Clinic, Kita-Katsuragi-gun, Nara, Japan.
⁹ Futata Tetsuhiro Clinic, Fukuoka, Fukuoka, Japan.

Abstract

Introduction: No study has compared the effects of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and dipeptidyl peptidase 4 inhibitors (DPP4is) on patients' quality-of-life (QOL).

Methods: We enrolled 253 drug-naïve Japanese patients with type 2 diabetes mellitus (T2DM), randomly assigned them into a dapagliflozin (SGLT2i) group or DPP4i group in approximately 1:1 ratio, and monitored them for 24 weeks. The primary endpoint was the proportion of subjects indicating improvement in the "overall quality of life" domain of SHIELD-WQ-9 at week 24. Secondary endpoints included other domains of SHIELD-WQ-9, DTR-QOL, EQ-5D-5L, medication preference, medication adherence, diet therapy adherence, body weight, body mass index (BMI), abdominal circumference, HbA1c, and frequency of adverse events.

Results: The proportion of subjects indicating improvement in the "overall quality of life" domain of SHIELD-WQ-9 at week 24 was higher in the dapagliflozin group (28.4%) than in the DPP4i group (18.6%) (p = 0.08). The proportion of subjects indicating improvement in the "physical health" domain of SHIELD-WQ-9 at week 24 was significantly higher in the dapagliflozin group (42.2%) than in the DPP4i group (23.7%) (p = 0.004). Total scores and domain 1 scores of DTR-QOL showed greater improvement in the dapagliflozin group (14.3 ± 15.6 and 15.5 ± 20.8, respectively) than in the DPP4i group (10.2 ± 15.6 and 10.3 ± 19.5, respectively) (both p = 0.05). EQ-5D-5L scores had significantly improved in the DPP4i group (0.023 ± 0.088) (p = 0.005); the intergroup difference was not significant (p = 0.14). Body weight (p < 0.001), BMI (p < 0.001), and abdominal circumference (p = 0.019) had significantly decreased in the dapagliflozin group compared with the corresponding values in the DPP4i group.

Conclusion: Dapagliflozin showed a comparable or more favorable benefit on Japanese patients' QOL compared with DPP4is. Dapagliflozin was well tolerated. It significantly reduced body weight, which was significantly correlated with improvement in the patients' QOL. This study demonstrates that dapagliflozin can be used as a first-line drug for T2DM in Japan with a beneficial impact on patients' QOL.

Trial registration: University Hospital Medical Information Network Clinical Trial Registry (UMIN000030514); Japan Registry of Clinical Trials (jRCTs051180165).

Keywords: Dapagliflozin; Dipeptidyl peptidase 4 inhibitor; Quality of life; Sodium–glucose cotransporter 2 inhibitor; Type 2 diabetes mellitus.