Efficacy, safety, and tolerability of ipragliflozin in Asian patients with type 2 diabetes mellitus and inadequate glycemic control with metformin: Results of a phase 3 randomized, placebo-controlled, double-blind, multicenter trial.

ABSTRACT:

Aims/introduction

To determine the efficacy and safety of ipragliflozin in combination with metformin in Asian patients with type 2 diabetes mellitus.

Materials and methods

This phase 3, multicenter, placebo-controlled, double-blind, parallel-group study was carried out at 18 sites in Korea and 12 sites in Taiwan. After an 8-week washout period for patients using drugs other than metformin and a 2-week run-in period, patients were randomized to either 50 mg ipragliflozin or a placebo for 24 weeks while continuing metformin. Efficacy outcomes included the changes in hemoglobin A1c, fasting plasma glucose (FPG) and bodyweight from baseline to the end of treatment (with last observation carried forward). Safety outcomes included treatment-emergent adverse events.

Results

SUBMITTER: Lu CH 

PROVIDER: S-EPMC4847891 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature