Glucose-lowering effects and safety of DS-8500a, a G protein-coupled receptor 119 agonist, in Japanese patients with type 2 diabetes: results of a randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase II study.

ABSTRACT:

Objective

DS-8500a is a novel G protein-coupled receptor 119 agonist being developed for the treatment of type 2 diabetes. The study objective was to assess the efficacy and safety of DS-8500a in Japanese patients with type 2 diabetes.

Research design and methods

In this double-blind, parallel-group, phase II study, 99 Japanese patients with type 2 diabetes were randomized to receive placebo, or DS-8500a 10 mg or 75 mg once daily for 28 days. The primary efficacy endpoint was change in the 24-hour weighted mean glucose (WMG) from baseline (day -1) to day 28. Other endpoints included changes in fasting plasma glucose, postprandial glucose, lipids, and safety.

Results

The 24-hour WMG decreased significantly after 28 days of treatment in the 10 mg and 75 mg groups with p

SUBMITTER: Inagaki N 

PROVIDER: S-EPMC5640040 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature