Efficacy and safety of the G protein-coupled receptor 119 agonist DS-8500a in Japanese type 2 diabetes mellitus patients with inadequate glycemic control on sitagliptin: A phase 2 randomized placebo-controlled study.

ABSTRACT:

Introduction

We evaluated the efficacy and safety of DS-8500a as add-on therapy to sitagliptin in Japanese type 2 diabetes mellitus patients.

Materials and methods

This multicenter, randomized, double-blind, placebo-controlled, phase 2 trial randomized patients aged ≥20 years with hemoglobin A1c ≥7.0% and <9.0%, and inadequate glycemic control with sitagliptin 50-mg monotherapy to receive 25 or 75 mg DS-8500a, or a placebo, orally. The primary end-point was change from baseline to day 28 in 24-h weighted mean glucose. Secondary end-points included change from baseline in fasting plasma glucose, 2-h postprandial plasma glucose and lipid profiles.

Results

Overall, 29, 28 and 27 patients in the placebo, 25- and 75-mg groups, respectively, were analyzed. A significant dos

SUBMITTER: Terauchi Y 

PROVIDER: S-EPMC6215943 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature