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

• Published in: Diabetes therapy Vol. 12; no. 3; pp. 655 - 667
• Main Authors: Yoshizawa, Yuta, Hosojima, Michihiro, Kabasawa, Hideyuki, Tanabe, Naohito, Ugamura, Daisuke, Koda, Yutaka, Shimada, Hisaki, Takasawa, Tetsuya, Ito, Takahito, Kitamura, Tadahiro, Kobayashi, Masaki, Suzuki, Yoshiki, Narita, Ichiei, Saito, Akihiko
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.03.2021; Springer; Springer Nature B.V
• Subjects: Blood sugar; Cardiology; Care and treatment; Control; Diabetes; Dosage and administration; Drug dosages; Drug therapy; Endocrinology; Health aspects; Hemodialysis; Hypoglycemia; Hypoglycemic agents; Inhibitor drugs; Internal Medicine; Medicine; Medicine & Public Health; Original Research; Patient outcomes; Type 2 diabetes; UMIN; UMIN000024284; Japan; Once-weekly dipeptidase 4 inhibitor; Linagliptin; Hemodialysis; Type 2 diabetes mellitus; Omarigliptin
• ISSN: 1869-6953; 1869-6961
• DOI: 10.1007/s13300-020-00991-y

Introduction Dipeptidyl 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. Methods This 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. Results Differences 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. Conclusions Our 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 Registration UMIN000024284.