164-LB: A Randomized Controlled Trial to Compare the Glycemic Effects of Dapagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, and Gliclazide Modified Release, a Sulfonylurea, Assessed by Continuous Glucose Monitoring among People with Type 2 Diabetes

Aims: This study aims to evaluate whether there is a difference between the effects of dapagliflozin and gliclazide MR (modified release) on glycemic variability (GV) and control, as assessed by continuous glucose monitoring (CGM), in individuals with uncontrolled type 2 diabetes (T2DM).

Methods: An open-label, randomized study was conducted in uncontrolled T2DM individuals drug naïve or on steady-dose metformin monotherapy which were treated with 10 mg dapagliflozin once daily or 60 to 120 mg of gliclazide MR once daily. CGM and GV indices calculation were performed at baseline and after 12 weeks.

Results: In total, 97 patients (age: 57.9 ± 8.7 years, male sex: 50.5%, baseline glycated hemoglobin (HbA1c): 7.9 ± 0.9) were randomized and 94 completed the 12-week protocol. Per protocol analysis demonstrated that the reduction of GV, as measured by the mean amplitude of glycemic excursions (MAGE), was superior in the dapagliflozin versus gliclazide MR group (-17.8 ± 33.3 vs. -3.3 ± 42.9 mg/dL, mean ± SD, p= 0.037). The improvement of GV, as measured by the coefficient of variation (CV) and the standard deviation (SD) was also superior in the dapagliflozin group (p=0.021 and 0.024, respectively). Moreover, dapagliflozin increased the time in range (TIR, between 70-180 mg/dL) by 28.6 ± 24.4% vs.19.8 ± 33.1 % (p=0.041). The intention-to-treat (ITT) analysis was also performed and did not alter the significance of the results.

Conclusions: Dapagliflozin reduced glycemic variability and increased the TIR more efficiently than gliclazide MR in individuals with T2DM after 12 weeks of treatment as demonstrated by continuous glucose monitoring evaluation.