3 years ago

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

Genki Kaneko, Kazuoki Kondo, Takashi Kadowaki, Nobuya Inagaki, Hiroaki Iijima, Maki Gouda, Nobuhiro Nakanishi, Yumi Watanabe, Kenichi Nishimura, Nobuko Maruyama
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 onto 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 randomised to receive add-on teneligliptin (20 mg; C + T group) or placebo (C + P group) for 24 weeks. The primary endpoint was the 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 <0.001). 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 onto ongoing canagliflozin improved glycaemic control and was well tolerated in Japanese patients with inadequately controlled T2DM.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/dom.13079

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