Objectives: To directly compare the long-term effectiveness and durability of sodium glucose co-transporter 2 (SGLT2) inhibitor, an empagliflozin-based quadruple therapy and insulin glargine-based therapy in patients with poorly controlled type 2 diabetes (T2D).
Research Design and Methods: Eligibility for this 3-year, open-label, prospective observational study was T2D patients (HbA1c, 7.5 - 12.0%) despite three distinct OADs (metformin, 2000 mg/day; dipeptidyl peptidase-4 inhibitor, maximal dose; and glimepiride ≥6 mg/day) between January 2017 and December 2021. Empagliflozin (25 mg/day, n = 167) or insulin glargine (n = 166) was added as the next agent. Outcomes included the time-to-treatment adjustment, changes in HbA1c level, and safety. Propensity score matched comparison and Kaplan-Meier estimation analysis were used.
Results: The estimated median time to treatment adjustment for empagliflozin group was 36.1 months (95% confidential interval [CI], 31.1 - 41.2), which was significantly longer than 18.3 months for the insulin glargine-based therapy (95% CI, 14.5 - 22.0). The mean change in HbA1c from baseline to month 36 were -1.5±1.0% and -1.0±1.4% in the empagliflozin group and the insulin glargine group, respectively (P=0.043). FPG showed a similar trend, although there was no statistical significance (-61.3±54.5 mg/dL vs -4.0±97.5 mg/dL, empagliflozin and insulin glargine group, respectively, P=0.129). Body weight showed a significant decrease in the empagliflozin group (-3.1±3.7 kg, P=0.003), whereas a significant increase in the insulin glargine group (3.2±2.6 kg, P<0.001).
Conclusions: This study demonstrated that the effectiveness of empagliflozin as a quadruple combination therapy has been sustained for 3 years. In general, empagliflozin treatment was better than insulin glargine-based combination therapy.
E.Ku: None. T.Oh: None.
