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

Expert Opin Pharmacother. 2017 Jun;18(8):743-751. doi: 10.1080/14656566.2017.1317748. Epub 2017 Apr 21.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Benzhydryl Compounds / administration & dosage
  • Benzhydryl Compounds / therapeutic use*
  • Blood Glucose / drug effects
  • Blood Pressure / drug effects
  • Body Composition
  • Body Weight / drug effects
  • Cross-Over Studies
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / metabolism
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Glucosides / administration & dosage
  • Glucosides / therapeutic use*
  • Glycated Hemoglobin / analysis
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / therapeutic use*
  • Intra-Abdominal Fat / drug effects
  • Japan
  • Male
  • Middle Aged
  • Overweight / complications
  • Overweight / drug therapy*
  • Overweight / metabolism
  • Sodium-Glucose Transporter 2
  • Sodium-Glucose Transporter 2 Inhibitors*
  • Treatment Outcome

Substances

  • Benzhydryl Compounds
  • Blood Glucose
  • Glucosides
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • SLC5A2 protein, human
  • Sodium-Glucose Transporter 2
  • Sodium-Glucose Transporter 2 Inhibitors
  • dapagliflozin