29-LB: A Multicenter, Randomized Controlled Study of the Efficacy of Once-Weekly DPP-4 Inhibitor Omarigliptin in Patients with Type 2 Diabetes Undergoing Maintenance Hemodialysis

Abstract

Background: DPP-4 inhibitors are used widely in patients with type 2 diabetes (T2D) undergoing maintenance hemodialysis (HD), but the efficacy of the once-weekly DPP-4 inhibitor omarigliptin (O) is unknown. Methods: This open, multicenter, randomized, non-inferiority trial compared glycemic control and safety of O and the daily DPP-4 inhibitor linagliptin (L) (UMIN000024284). We enrolled 33 T2D patients undergoing maintenance HD, who had been treated with L for at least 3 months at Niigata University Medical and Dental Hospital and three affiliated dialysis facilities between April 2017 and March 2018. The patients were randomized to receive O (n = 16) or L (n = 17). Primary endpoints were changes in HbA1c and glycoalbumin (GA) over 24 weeks from baseline (with non-inferiority margins of 0.25% and 0.75%, respectively). Secondary endpoints were changes in blood glucose and plasma glucagon measured by sandwich ELISA after single HD and the incidence of adverse events including hypoglycemia. Results: In the full analysis set (n = 30), the difference in the mean change in primary endpoint values between the O and L groups was −0.6% for HbA1c and −1.7% for GA, with one-tailed upper 95% limits of −0.17% and 0.4%, respectively, below the respective non-inferiority limits. HbA1c reduction was significantly greater in the O group (−0.2% ± 0.6%) than in the L group (0.4% ± 0.8%, two-tailed p = 0.027). Blood glucose reduction after single HD was significantly greater in the O group (−18.4 ± 31.4 mg/dL) than in the L group (25.2 ± 59.5 mg/dL, two-tailed p = 0.025), but plasma glucagon reduction after single HD was not greater in the O group (−6.8 ± 14.1 pg/dL) than in the L group (2.6 ± 16.6 pg/dL, two-tailed p = 0.11). No subjects in the O group experienced hypoglycemia. Conclusion: Omarigliptin is feasible for glycemic control in T2D patients undergoing maintenance HD. Further studies are needed to determine the mechanisms of its efficacy. Disclosure Y. Yoshizawa: None. M. Hosojima: Research Support; Self; Astellas Pharma Inc., Biotech Japan Corporation, Daiichi Sankyo Co.,Ltd., Eli Lilly Japan K.K., Forica Foods Co.,Ltd., Kameda Seika Co.,Ltd., Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Novo Nordisc Pharma Ltd., Sato Foods Industries Co.,Ltd., Taisho Toyama Pharmaceutical.Co.,Ltd., Takeda Pharmaceutical Co.,Ltd. H. Kabasawa: Research Support; Self; Astellas Pharma Inc., Biotec Japan Corporation, Daiichi Sankyo Company, Limited, Forica Foods CO.,LTD., KAMEDA SEIKA CO., LTD., Kyowa Hakko Kirin Co., Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K, Novo Nordisc Pharma Ltd, Sato Foods Industries CO.,LTD., Taisho Toyama Pharmaceutical.CO.,LTD., Takeda Pharmaceutical Company Limited. N. Tanabe: None. T. Kitamura: None. I. Narita: None. A. Saito: None.