Abstract
The Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT) clinical trial programme, showed that for patients with type 1 diabetes mellitus (T1DM) inadequately controlled by insulin alone, adjunct dapagliflozin (10mg or 5mg) reduced body weight and improved glycaemic control, without increased risk of hypoglycaemia versus placebo. Incidence and related fear of hypoglycaemia and weight gain are among factors that influence patient-reported outcomes, such as quality of life and treatment satisfaction. This study aimed to assess the impact of dapagliflozin on patient-reported treatment satisfaction in DEPICT. Patient treatment satisfaction was measured via the Diabetes Treatment Satisfaction Questionnaire (DTSQ) total score. All patients from DEPICT (consisting of the DEPICT-1 and DEPICT-2 trials) with complete DTSQ measurements were eligible for inclusion in the analysis. The proportion of patients achieving a 3-point improvement in DTSQ total score from baseline was evaluated at week 24 and week 52. Statistical significance of differences in observed proportions between study arms was assessed using a Z-test of proportions. A higher proportion of patients treated with dapagliflozin achieved at least a 3-point increase in DTSQ total score compared to placebo over 24 weeks (dapagliflozin 10mg: 37%; dapagliflozin 5mg; 39%, placebo: 28%) and 52 weeks (dapagliflozin 10mg: 43%; dapagliflozin 5mg: 37%; placebo: 32%). At both doses, statistically significant differences were observed between dapagliflozin and placebo at 24 weeks (10mg: p=0.002; 5mg: p<0.001). At 52 weeks a significant difference was observed between dapagliflozin 10mg and placebo (p=0.001), but the difference between dapagliflozin 5mg and placebo was not statistically significant. The results of this study demonstrated that treatment with dapagliflozin was associated with an improvement in treatment satisfaction compared to placebo. Together with improvements in glycaemic control, weight and incidence of hypoglycaemia, improvements in patient-reported outcomes support the role of dapagliflozin in T1DM management.
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