Efficacy and safety of teneligliptin added to canagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: A multicentre, randomized, double-blind, placebo-controlled, parallel-group comparative study

Takashi Kadowaki, Nobuya Inagaki, Kazuoki Kondo, Kenichi Nishimura, Genki Kaneko, Nobuko Maruyama, Nobuhiro Nakanishi, Maki Gouda, Hiroaki Iijima, Yumi Watanabe, Takashi Kadowaki, Nobuya Inagaki, Kazuoki Kondo, Kenichi Nishimura, Genki Kaneko, Nobuko Maruyama, Nobuhiro Nakanishi, Maki Gouda, Hiroaki Iijima, Yumi Watanabe

Abstract

Dipeptidyl peptidase-4 (DPP-4) inhibitors and sodium glucose co-transporter 2 (SGLT2) inhibitors are frequently used in combination for the treatment of type 2 diabetes mellitus (T2DM). We examined the efficacy and safety of teneligliptin (a DPP-4 inhibitor) added to canagliflozin (an SGLT2 inhibitor) monotherapy in Japanese patients with poorly controlled T2DM as part of the development of a fixed-dose combination of teneligliptin and canagliflozin. Japanese patients treated with canagliflozin (100 mg) for ≥12 weeks were randomized to receive add-on teneligliptin (20 mg; C + T group) or placebo (C + P group) for 24 weeks. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to Week 24. The between-group differences in reductions from baseline to Week 24 were significantly greater in the C + T group for HbA1c (-0.94%; P < .001). The incidence of adverse events was similar in both groups (55.8% and 49.4% in the C + T and C + P groups, respectively). No episodes of hypoglycaemia were reported. Teneligliptin added to ongoing canagliflozin monotherapy improved glycaemic control and was well tolerated in Japanese patients with inadequately controlled T2DM.

Keywords: canagliflozin; dipeptidyl peptidase-4 inhibitor; sodium glucose co-transporter 2 inhibitor; teneligliptin; type 2 diabetes mellitus.

Conflict of interest statement

T. K. has received consulting fees and/or speakers' bureau fees from Astellas Pharma Inc., AstraZeneca K.K., MSD K.K., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Takeda Pharmaceutical Co., Ltd., Eli Lilly Japan K.K. and Nippon Boehringer Ingelheim Co., Ltd.; has received research support from Daiichi Sankyo Co., Ltd. and Takeda Pharmaceutical Co., Ltd.; has received scholarship grants from Astellas Pharma Inc., Daiichi Sankyo Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Sumitomo Dainippon Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Novo Nordisk Pharma Ltd., Sanofi K.K. and Ono Pharmaceutical Co., Ltd.; and teaches courses endowed by MSD K.K., Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Kowa Pharmaceutical Co., Ltd. and Ono Pharmaceutical Co., Ltd. N. I. has received consulting fees and/or speakers' bureau fees from Astellas Pharma Inc., MSD K.K., Nippon Boehringer Ingelheim Co., Ltd., Sanofi K.K. and Takeda Pharmaceutical Co., Ltd.; has received research support from Eli Lilly Japan K.K., MSD K.K. and Mitsubishi Tanabe Pharma Corporation; and has received scholarship grants from Astellas Pharma Inc., AstraZeneca K.K., Daiichi Sankyo Co., Ltd., Japan Diabetes Foundation, Japan Tobacco Inc., Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., MSD K.K., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanwa Kagaku Kenkyusho Co., Ltd., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd. and Taisho Pharmaceutical Co., Ltd. K. K., K. N., G. K., N. M., N. N., M. G., H. I. and Y. W. are employees of Mitsubishi Tanabe Pharma Corporation.

© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Changes in HbA1c from baseline to each visit during the 24‐week treatment period, and at the last observation carried forward. Values are expressed as the least squares mean ± standard error. The least squares mean was determined by analysis of covariance with treatment group as a fixed factor and the baseline value as a covariate. *P < .001 for the C + T group vs C + P group at all time points. C + P, canagliflozin plus placebo; C + T, canagliflozin plus teneligliptin; HbA1c, glycated haemoglobin; LOCF, last observation carried forward; LS mean, least squares mean

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