Results
As shown in Table 1, the overall characteristics of the two groups of patients were well matched at baseline. There were also no significant differences in indexes derived from CGM between the groups at baseline.
CGM showed that 24-hour mean glucose and postprandial glucose after each meal decreased significantly after treatment with tofogliflozin in patients receiving or not receiving DPP-4 inhibitors (Fig. 1A and B, and Table 2). Time in range increased significantly after treatment in both the group receiving DPP-4 inhibitors (from 54.9% ± 27.8% to 78.2% ± 22.2%, respectively; P = 0.0120) and the group not receiving them (from 65.5% ± 33.9% to 83.9% ± 20.2%, respectively; P = 0.0276), and time above range significantly decreased in both groups (Table 2).
After treatment with tofogliflozin, the SD of 24-hour glucose significantly decreased in the group receiving DPP-4 inhibitors (from 40.80 ± 17.89 mg/dL to 29.70 ± 10.23 mg/dL, P = 0.0108; Table 2) but did not significantly change in the group not receiving DPP-4 inhibitors (P=0.1028). In patients receiving DPP-4 inhibitors, MAGE was significantly reduced (from 98.8 ± 41.6 mg/dL to 70.9 ± 29.3 mg/dL, P = 0.0066), as was MPPGE (from 77.2 ± 41.8 mg/dL to 63.8 ±3 2.1 mg/dL, P = 0.0378); however, both these indexes of glycemic variability were unchanged in patients not receiving DPP-4 inhibitors (Table 2).