The effects of intermittent use of the SGLT-2 inhibitor, dapagliflozin, in overweight patients with type 2 diabetes in Japan: a randomized, crossover, controlled clinical trial

ABSTRACT

Background: This study examined the effects of short-term administration of the sodium glucose cotransporter 2 (SGLT-2) inhibitor, dapagliflozin, on visceral fat area (VFA) in Japanese patients with type 2 diabetes.

Research design and methods: In this randomized, crossover, controlled clinical trial, overweight patients with type 2 diabetes were randomized to treatment with 5 mg dapagliflozin for the first (n = 27) or second 12-week study period (n = 29). The parameters evaluated at baseline and after 12 and 24 weeks included blood pressure, hemoglobin A1c (HbA1c), body composition, VFA, and subcutaneous fat area (SFA).

Results: In both groups, dapagliflozin administration improved the levels of HbA1c, body weight, blood pressure, total fat mass, and VFA. Cessation of dapagliflozin, however, reversed the improvements in HbA1c, blood pressure, body weight, and SFA levels, whereas reductions in VFA and total fat mass levels were somewhat maintained even after 12 weeks without treatment.

Conclusions: Dapagliflozin led to decreases in VFA and, consequently, body weight after a short treatment period. However, these effects were largely reversed by the cessation of dapagliflozin, suggesting that this agent should be administered continuously to maintain clinical usefulness in overweight patients with type 2 diabetes.

KEYWORDS:

• Dapagliflozin
• SGLT-2 inhibitor
• total fat mass
• type 2 diabetes
• visceral fat area

Acknowledgments

The authors thank all the study participants and acknowledge Ms. Atsumi Kezuka for her excellent technical assistance. We would like to thank Editage (www.editage.jp) for English language editing.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This work was supported by Dokkyo Medical University Investigator-Initiated Research under Grant no. 2016-09 to M Sagara.

Notes on contributors

Kanako Kato

K Kato, K Suzuki, M Sagara, and Y Aso designed the research; K Kato, K Suzuki, C Aoki, M Sagara, T Niitani, S Wakamatsu, and K Yanagi performed the research; K Kato, K Suzuki, C Aoki, and K Yanagi analyzed data; and K Kato, K Suzuki, and Y Aso wrote the paper. All authors read and approved the final manuscript.

Kunihiro Suzuki

K Kato, K Suzuki, M Sagara, and Y Aso designed the research; K Kato, K Suzuki, C Aoki, M Sagara, T Niitani, S Wakamatsu, and K Yanagi performed the research; K Kato, K Suzuki, C Aoki, and K Yanagi analyzed data; and K Kato, K Suzuki, and Y Aso wrote the paper. All authors read and approved the final manuscript.

Chie Aoki

K Kato, K Suzuki, M Sagara, and Y Aso designed the research; K Kato, K Suzuki, C Aoki, M Sagara, T Niitani, S Wakamatsu, and K Yanagi performed the research; K Kato, K Suzuki, C Aoki, and K Yanagi analyzed data; and K Kato, K Suzuki, and Y Aso wrote the paper. All authors read and approved the final manuscript.

Masaaki Sagara

K Kato, K Suzuki, M Sagara, and Y Aso designed the research; K Kato, K Suzuki, C Aoki, M Sagara, T Niitani, S Wakamatsu, and K Yanagi performed the research; K Kato, K Suzuki, C Aoki, and K Yanagi analyzed data; and K Kato, K Suzuki, and Y Aso wrote the paper. All authors read and approved the final manuscript.

Takafumi Niitani

K Kato, K Suzuki, M Sagara, and Y Aso designed the research; K Kato, K Suzuki, C Aoki, M Sagara, T Niitani, S Wakamatsu, and K Yanagi performed the research; K Kato, K Suzuki, C Aoki, and K Yanagi analyzed data; and K Kato, K Suzuki, and Y Aso wrote the paper. All authors read and approved the final manuscript.

Sho Wakamatsu

K Kato, K Suzuki, M Sagara, and Y Aso designed the research; K Kato, K Suzuki, C Aoki, M Sagara, T Niitani, S Wakamatsu, and K Yanagi performed the research; K Kato, K Suzuki, C Aoki, and K Yanagi analyzed data; and K Kato, K Suzuki, and Y Aso wrote the paper. All authors read and approved the final manuscript.

Kazunori Yanagi

K Kato, K Suzuki, M Sagara, and Y Aso designed the research; K Kato, K Suzuki, C Aoki, M Sagara, T Niitani, S Wakamatsu, and K Yanagi performed the research; K Kato, K Suzuki, C Aoki, and K Yanagi analyzed data; and K Kato, K Suzuki, and Y Aso wrote the paper. All authors read and approved the final manuscript.

Yoshimasa Aso

K Kato, K Suzuki, M Sagara, and Y Aso designed the research; K Kato, K Suzuki, C Aoki, M Sagara, T Niitani, S Wakamatsu, and K Yanagi performed the research; K Kato, K Suzuki, C Aoki, and K Yanagi analyzed data; and K Kato, K Suzuki, and Y Aso wrote the paper. All authors read and approved the final manuscript.