ABSTRACT
BACKGROUND: The benefits of sodium glucose cotransporters 2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus include plasma glucose control, reduction in body weight and blood pressure, and low risk of hypoglycemia, although they may also cause genitourinary infections, polyuria, or volume depletion. It is not clear whether dapagliflozin, an SGLT2 inhibitor, improves treatment satisfaction among patients in a comprehensive way despite the negative side effects. This study assessed the effect of dapagliflozin on glycosylated hemoglobin (HbA1c), body weight, and treatment satisfaction in overweight patients with type 2 diabetes mellitus treated with oral hypoglycemic agents. METHODS: This multicenter, open-label, single-arm observational study included patients with type 2 diabetes mellitus administering dapagliflozin 5 or 10 mg per day for 14 weeks. Changes in treatment satisfaction were evaluated using a new version of the Oral Hypoglycemic Agent-Questionnaire (OHA-Q ver. 2) consisting of 23 items. Correlation between treatment satisfaction and HbA1c levels and body weight were analyzed using the Spearman's rank-correlation coefficient. RESULTS: Of the 221 patients enrolled, 188 completed the study. Mean HbA1c decreased from 7.8 ± 0.7% (62.1 ± 7.5 mmol/mol) to 7.3 ± 0.8% (55.9 ± 8.7 mmol/mol) (change - 0.6 ± 0.7%, P < 0.001) and body weight decreased from 82.5 ± 14.6 to 80.7 ± 14.8 kg (change - 2.3 ± 2.8 kg, P < 0.001). OHA-Q ver. 2 was validated as well, the mean OHA-Q ver. 2 total score increased from 44.3 ± 9.4 to 46.6 ± 9.8 (best score 69, worst score 0; change 2.3 ± 6.6, P < 0.001). The change in body weight significantly correlated with the OHA-Q ver. 2 total score (Spearman's ρ = - 0.17, P = 0.035). The change in HbA1c levels significantly correlated with the satisfaction subscale score (Spearman's ρ = - 0.19, P = 0.011). CONCLUSIONS: Dapagliflozin significantly improved treatment satisfaction among patients with type 2 diabetes mellitus for 14 weeks. Body weight loss significantly correlated with treatment satisfaction.Trial registration UMIN-CTR: UMIN000016304.
ABSTRACT
BACKGROUND: In addition to achieving good glycemic control, diabetes care management aims to improve the quality of life (QOL) in patients. Treatment-associated difficulties and side effects frequently cause deterioration in QOL. Liraglutide, a GLP-1 receptor agonist, is a novel injection drug that promotes insulin secretion. It is a user-friendly, once-daily injection with fewer hypoglycemic events. In this study, we aimed to examine the effect of liraglutide therapy on QOL in patients. METHODS: In total, 304 insulin- and liraglutide-naïve patients with type 2 diabetes were enrolled in this observational study; they received liraglutide therapy for 12 weeks. The main outcome measure was change in QOL from baseline, which was assessed using diabetes therapy-related QOL (DTR-QOL). RESULTS: At week 12, liraglutide significantly decreased HbA1c levels (8.7 ± 1.5 vs. 7.5 ± 1.3, p < 0.001) and BMI (27.9 ± 5.3 vs. 27.3 ± 5.2, p < 0.001). According to the QOL scores, although the treatment modality had changed from non-injection to injection therapy, liraglutide improved patient satisfaction with treatment. Significant correlations were found between change in HbA1c level and satisfaction with treatment, as well as between change in body weight and burden on social and daily activities, anxiety and dissatisfaction with treatment, and hypoglycemia. CONCLUSIONS: Liraglutide significantly improved glycemic control and reduced the body weight without deteriorating QOL in obese patients with type 2 diabetes. Trial registration UMIN-CTR: UMIN000007159.