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Long‐term safety and efficacy of canagliflozin as add‐on therapy to teneligliptin in J apanese patients with type 2 diabetes
Author(s) -
Kadowaki Takashi,
Inagaki Nobuya,
Kondo Kazuoki,
Nishimura Kenichi,
Kaneko Genki,
Maruyama Nobuko,
Nakanishi Nobuhiro,
Watanabe Yumi,
Gouda Maki,
Iijima Hiroaki
Publication year - 2018
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13038
Subject(s) - medicine , canagliflozin , type 2 diabetes , adverse effect , postprandial , clinical endpoint , confidence interval , incidence (geometry) , diabetes mellitus , glycated hemoglobin , gastroenterology , endocrinology , randomized controlled trial , insulin , physics , optics
Aim To evaluate the long‐term safety and efficacy of canagliflozin as add‐on therapy in patients with type 2 diabetes mellitus ( T2DM ) who had inadequate glycaemic control with teneligliptin monotherapy. Methods This open‐label 52‐week study was conducted in J apan. Patients received canagliflozin 100 mg added to teneligliptin 20 mg orally once daily for 52 weeks. The safety endpoint was the incidence of adverse events ( AE s). The efficacy endpoints included changes in glycated haemoglobin ( HbA1c ), fasting plasma glucose ( FPG ) and body weight from baseline to week 52 (with last observation carried forward). Results Overall, 153 patients entered the treatment period and 142 completed the study. The overall incidence rates of AE s and drug‐related AE s were 69.9% and 22.9%, respectively. Most AE s and drug‐related AE s were mild or moderate in severity. There were no previously undescribed safety signals. The mean changes in HbA1c , FPG and body weight were −0.99% (95% confidence interval [ CI ] −1.12 to −0.85), −38.6 mg/dL (95% CI −43.4 to −33.9) and −3.92% (95% CI −4.53 to −3.31), respectively. These effects were maintained for 52 weeks without attenuation. HbA1c and body weight were both decreased in 82.24% of patients at the end of the treatment period. Reductions in postprandial glucose were observed at weeks 24 and 52. Conclusions No new safety risks with this combination were identified, and sustained improvements in HbA1c , FPG and body weight were observed. The findings suggest that long‐term co‐administration of canagliflozin with teneligliptin is well tolerated and effective in J apanese patients with T2DM who have inadequate glycaemic control on teneligliptin alone.