Aims: This study evaluated change in health-related quality of life (HRQOL) associated with ongoing weight change among patients with type 2 diabetes mellitus (T2DM) treated with dapagliflozin, a highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that lowers blood glucose by increasing urinary glucose excretion and is associated with body weight reductions.
Methods: Patients with T2DM who had inadequate glycaemic control on metformin (MET) alone were enrolled in a 24-week, double-blind, randomized, placebo-controlled study with a 78-week extension to evaluate the effect of dapagliflozin + MET on body weight. Patients also completed the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes Weight Questionnaire-9 (SHIELD-WQ-9), a weight change-related HRQOL survey. Difference in proportions of patients treated with dapagliflozin 10 mg + MET (n = 89) or placebo + MET (n = 91) who reported improvement in HRQOL was analysed with Fisher's exact test.
Results: Dapagliflozin patients had significantly greater weight loss than placebo patients over 102 weeks (p < 0.05). This corresponded to a numerically greater proportion of dapagliflozin-treated patients reporting ongoing weight loss and associated improvements in most HRQOL domains at three different evaluation points (weeks 24, 50 and 102) than placebo-treated patients. In a post-hoc analysis among patients who reported ongoing weight loss regardless of treatment arm, a significantly greater proportion of patients reporting weight loss versus weight gain reported improvements in physical health, self-esteem and overall HRQOL at weeks 24, 50 and 102.
Conclusions: Dapagliflozin-induced weight loss was associated with improvement in overall HRQOL. Overall, ongoing weight loss was associated with improvements in several HRQOL domains compared with weight gain.
Keywords: SGLT2 inhibitor; antidiabetic drug; clinical trial; diabetes mellitus; human adipose tissue; randomized trial.
© 2014 John Wiley & Sons Ltd.