Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus.

ABSTRACT:

Aim

To evaluate the efficacy/safety of canagliflozin twice daily (BID) compared with placebo in patients with type 2 diabetes mellitus (T2DM) on metformin.

Methods

In this 18-week, randomized, double-blind, placebo-controlled study, patients (N = 279) at 60 centers in 7 countries received canagliflozin 50 or 150 mg or placebo BID. The pre-specified primary endpoint was change from baseline in HbA_1c at Week 18. Pre-specified secondary endpoints included proportion of patients reaching HbA_1c <7.0%, change in fasting plasma glucose (FPG), and percent change in body weight; changes in systolic blood pressure (BP) and fasting plasma lipids were also evaluated. Adverse events (AEs) were recorded throughout the study.

Results

From a mean baseline

SUBMITTER: Qiu R 

PROVIDER: S-EPMC5685027 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature