The efficacy and safety of luseogliflozin and sitagliptin depending on the sequence of administration in patients with type 2 diabetes mellitus: a randomized controlled pilot study

Abstract

ABSTRACTBackground: The efficacy and safety of SGLT-2 and DPP-4 inhibitor monotherapies in T2DM is well established; however, data on the effect of combination therapies and sequence of administration are lacking. We investigated the efficacy and safety of the sequence of SGLT-2 and DPP-4 inhibitor administration in Japanese T2DM patients.Research design and methods: In this single-institution, open-label, randomized controlled study, T2DM patients inadequately controlled (HbA1c ≥6.5%) with conventional therapy were randomized to receive luseogliflozin-sitagliptin (LS; luseogliflozin 2.5 mg for 0–12 weeks, then luseogliflozin plus sitagliptin 50 mg for 12–24 weeks) or sitagliptin-luseogliflozin (SL; sitagliptin 50 mg for 0–12 weeks, then sitagliptin plus luseogliflozin 2.5 mg for 12–24 weeks). The main outcome was the difference in mean change in HbA1c at 24 weeks relative to baseline between both groups.Results: Of the 41 enrolled and randomized patients, 34 completed the study. Mean ± SD HbA1c at baseline was 10.35 ± 1.04% and 10.02 ± 1.40% in the LS and SL groups, respectively, and mean ± SD change in HbA1c at 24 weeks from baseline was −3.81 ± 1.21% vs −2.46 ± 1.42% (P < 0.01), respectively. No drug-related adverse events were reported.Conclusion: Over the 24-week period, LS was more effective in reducing HbA1c levels than SL in Japanese T2DM patients.