Advertisement

 

 

Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: results of a 24-week, randomised, double-blind, placebo-controlled trial.

Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: results of a 24-week, randomised, double-blind, placebo-controlled trial.
Author Information (click to view)

Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Iijima H, Watanabe Y, Gouda M,


Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Iijima H, Watanabe Y, Gouda M, (click to view)

Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Iijima H, Watanabe Y, Gouda M,

Advertisement

Diabetes, obesity & metabolism 2017 02 08() doi 10.1111/dom.12898
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, randomised, double-blind, placebo-controlled, phase 3 clinical trial in Japanese patients with T2DM who had inadequate glycaemic control with teneligliptin. Patients were randomised 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 the HbA1c change from baseline to week 24 was -0.88% (least-squares mean, p < 0.001). Fasting plasma glucose, body weight, and the proinsulin/C-peptide ratio were significantly lower in the T + C group than 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-h 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. The 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.

Submit a Comment

Your email address will not be published. Required fields are marked *

eighteen − seventeen =

[ HIDE/SHOW ]