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.

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?

SUBMITTER: Kadowaki T 

PROVIDER: S-EPMC5484989 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature