Effects of the Once-Weekly DPP4 Inhibitor Omarigliptin on Glycemic Control in Patients with Type?2 Diabetes Mellitus on Maintenance Hemodialysis: A 24-Week Open-Label, Multicenter Randomized Controlled Study

摘要

IntroductionDipeptidyl peptidase?4 (DPP4) inhibitors are widely used in patients with type?2 diabetes mellitus (T2DM) on maintenance hemodialysis (HD), but the efficacy of the once-weekly DPP4 inhibitor omarigliptin is not known.MethodsThis prospective, randomized, open-label, parallel-group, non-inferiority/superiority, once-daily DPP4 inhibitor linagliptin-controlled, multicenter study examined glycemic control and safety of omarigliptin (UMIN000024284). Sample size was calculated to confirm non-inferiority in terms of changes in glycated hemoglobin (HbA1c). We enrolled 33 patients with T2DM on maintenance HD who had been treated with linagliptin for at least 3?months. The patients were randomized to receive omarigliptin (12.5?mg/week; n =?16) or linagliptin (5?mg/day; n =?17). Primary endpoints were changes in HbA1c and glycoalbumin (GA) over 24?weeks.ResultsDifferences in the mean change in primary endpoint values between the omarigliptin and linagliptin groups were???0.61% [??1.14, ??0.09] for HbA1c, with a two-tailed upper 95% limit (i.e., one-tailed 97.5% upper limit) of 0.25%, below the non-inferiority limit, and ??1.67% [??4.23,? ?0.88] for GA, with a two-tailed upper 95% limit of 0.75%, above the non-inferiority limit. At 24?weeks, the omarigliptin group showed significantly greater reduction in HbA1c than the linagliptin group (??0.2%?±?0.6% vs. 0.4%?±?0.8%, two-tailed p =?0.024) and significantly greater reduction in blood glucose after a single HD session (??18.4?±?31.4?mg/dL vs. 25.2?±?59.5?mg/dL, respectively, two-tailed p =?0.019). No subjects in the omarigliptin group developed hypoglycemia.ConclusionsOur data showed that omarigliptin was non-inferior to linagliptin in glycemic control. Omarigliptin is feasible for glycemic control in patients with T2DM on maintenance HD.Clinical Trials RegistrationUMIN000024284.