Continuous Glucose Monitoring-Based Metrics with Fixed-Dose Combination Versus Co-administered Dapagliflozin/Metformin in Chinese Patients with Type 2 Diabetes Mellitus

Abstract Background Dapagliflozin plus metformin provides effective glycemic control with cardiorenal protection in type 2 diabetes mellitus (T2DM), and fixed-dose combination (FDC) reduces pill burden. This is the first study comparing continuous glucose monitoring (CGM) metrics of dapagliflozin/metformin FDC versus co-administration worldwide. Methods In the 24-week, multicenter, randomized EFFICIENT study, Chinese adults with newly diagnosed T2DM received dapagliflozin/metformin FDC or co-administration. CGM metrics were collected at Week 12, including percentage of time in tight range (TITR), time in range (TIR), time above range (TAR), time below range (TBR), mean amplitude of glycemic excursion (MAGE) and standard deviation of blood glucose (SDBG). Results The CGM analysis included 305 patients. Among those with sufficient evaluable traces (FDC: 149; co-administration: 144), the median TITR was 71.5% versus 75.0% (difference: −3.07%; 95% CI [− 7.16%, 0.81%]; nominal p = 0.13). Median TIR, TAR, and TBR were 90.7% versus 93.4%, 7.5% versus 6.3%, and 0.0% versus 0.0%, respectively. Median MAGE and SDBG were 2.7 mmol/L and 1.6 mmol/L, respectively, for both groups. Conclusions This study provided the first CGM data of dapagliflozin/metformin FDC worldwide, demonstrating glycemic control well above recommended targets. FDC had comparable efficacy to co-administration while reducing pill burden, providing an effective and simplified alternative for T2DM. Trial registration: ClinicalTrials.gov, NCT06327815