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- Title
Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, placebo-controlled trial.
- Authors
Kadowaki, Takashi; Inagaki, Nobuya; Kondo, Kazuoki; Nishimura, Kenichi; Kaneko, Genki; Maruyama, Nobuko; Nakanishi, Nobuhiro; Iijima, Hiroaki; Watanabe, Yumi; Gouda, Maki
- Abstract
Aims To investigate efficacy and safety of the sodium-glucose co-transporter 2 ( SGLT2) inhibitor canagliflozin administered as add-on therapy to the dipeptidyl peptidase-4 ( DPP-4) inhibitor teneligliptin in patients with type 2 diabetes mellitus ( T2DM). Materials and methods We conducted a multicentre, randomized, double-blind, placebo-controlled, phase 3 clinical trial in Japanese patients with T2DM who had inadequate glycaemic control with teneligliptin. Patients were randomized to receive teneligliptin 20 mg plus either canagliflozin 100 mg ( T + C, n = 70) or placebo ( T + P, n = 68) once daily. The primary endpoint was the change in glycated haemoglobin ( HbA1c) from baseline to week 24. Other endpoints included changes in fasting plasma glucose, body weight, proinsulin/ C-peptide ratio, homeostatic model assessment 2-% B and adverse events. Patients also underwent mixed-meal tolerance tests. Results The difference between the T + C and T + P groups for HbA1c change from baseline to week 24 was −0.88% (least-squares mean, P < .001). Fasting plasma glucose, body weight and the proinsulin/ C-peptide ratio were significantly lower in the T + C group than in the T + P group. Homeostatic model assessment 2-% B improved with T + C compared with T + P. The T + C group exhibited a decrease in the 2-hour postprandial plasma glucose and plasma glucose area under the curve ( AUC)0-2h in a mixed-meal tolerance test. No significant between-group differences were observed for C-peptide AUC0-2h or glucagon AUC0-2h after meals. Incidences of adverse events were 60.0% and 47.1% in the T + C and T + P groups, respectively. No hypoglycaemia was observed. Conclusions Canagliflozin administered as add-on therapy to teneligliptin was effective and well tolerated in Japanese T2DM patients.
- Subjects
CANAGLIFLOZIN; CD26 antigen; SODIUM-glucose cotransporters; TYPE 2 diabetes; DRUG efficacy
- Publication
Diabetes, Obesity & Metabolism, 2017, Vol 19, Issue 6, p874
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12898