Background
Dapagliflozin, a sodium glucose co-transporter 2 inhibitors (SGLT-2i), have demonstrated efficacy of glycemic control in patients with type 2 diabetes mellitus (T2DM). However, previous data in real world setting with a large patient number from an Asian population were limited.

Aims
To investigate the glycemic control profile of dapagliflozin in Taiwanese T2DM patients under real world clinical setting.

Method
This was a multicenter, retrospective observational study (ClinicalTrials.gov, no. NCT03084965) enrolling patients with T2DM exposed to dapagliflozin since its reimbursement in Taiwan May 2016. The primary objective was to evaluate glycated hemoglobin (A1c) change from baseline after 6 months treatment. Changes in other parameters including fasting plasma glucose (FPG), body weight (BW), body mass index (BMI), blood pressure and lipid profiles at 3, and 6 months were also assessed as secondary objectives if data was available.

Results
There were 1960 patients (mean age was 57.8 years, 52% men, mean [SD, standard deviation] A1c was 8.76% [1.44]) enrolled in the study. At baseline, 92% of patients were with metformin, 71% with sulfonylurea, 54% with DPP4i and 30% with insulin. There were 46.17% patients starting dapagliflozin as add-on therapy and 53.83% patients as switching. After 6 months treatment, the mean change (95% CI, Confidence Interval) from baseline in A1c, BW, BMI and FPG were -0.73% (-0.80, -0.67), -1.61kg (-1.79, -1.42), -0.60 kg/m2 (-0.67, -0.54) and -28.3 mg/dL (-31.6, -25.1), respectively (all p<0.0001). The mean change (95% CI) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) were -3.6 mmHg (-4.6, -2.6) and -1.4 mmHg (-2.0, -0.7), respectively (both p<0.001). The mean change in lipid profiles were listed below as 2.9 mg/dL in total cholesterol, -16.6 mg/dL in triglycerides, 1.1 mg/dL in LDL, and 2.4 mg/dL in HDL. There were 64.4% patients with reduction in both A1c and BW. The multivariable logistic regression analysis showed that higher baseline A1c and receiving dapagliflozin as add-on were significantly (p<0.0001 and p=0.0017, respectively) associated with greater A1c reduction.

Discussion
Dapagliflozin demonstrates benefit of glycemic control and body weight reduction under real-world clinical setting in Taiwan. With more than one thousand patients’ data collection, the study identified factors, including higher baseline A1c, and using dapagliflozin as add-on therapy, were associated with greater benefit of glycemic control from dapagliflozin.

A retrospective study of patients with type 2 diabetes mellitus on dapagliflozin in Taiwan