Efficacy and Safety of GPR119 Agonist DS-8500a in Japanese Patients with Type 2 Diabetes: a Randomized, Double-Blind, Placebo-Controlled, 12-Week Study.

Advances in Therapy
Yuichiro YamadaTakashi Taguchi

Abstract

G protein-coupled receptor 119 (GPR119) is a promising target for the treatment of type 2 diabetes mellitus (T2DM), as both insulin and glucagon-like peptide-1 secretion can be promoted with a single drug. We compared the efficacy and safety of the GPR119 agonist DS-8500a with placebo and sitagliptin 50 mg in Japanese patients with T2DM. This randomized, double-blind, parallel-group comparison study was conducted in Japan (trial registration NCT02628392, JapicCTI-153068). Eligible patients aged ≥ 20 years with T2DM and hemoglobin A1c (HbA1c) ≥ 7.0% and < 10.0% were randomized to receive placebo, DS-8500a (25, 50, or 75 mg), or sitagliptin 50 mg once daily for 12 weeks. The primary efficacy endpoint was change in HbA1c from baseline to week 12. Secondary endpoints included change in fasting plasma glucose (FPG), glucose AUC0-3h during a meal tolerance test, 2-hour postprandial glucose (2hr-PPG), and changes in lipid parameters (total, low-density lipoprotein (LDL-) and high-density lipoprotein (HDL-) cholesterol, and triglycerides) at week 12. Safety endpoints included adverse events, hypoglycemia, and clinical/laboratory variables. DS-8500a demonstrated dose-dependent HbA1c lowering compared with placebo at week 12: change from...Continue Reading

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Citations

Oct 27, 2018·Frontiers in Endocrinology·Silvano Paternoster, Marco Falasca
Sep 16, 2020·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Zhiwei ZengTao Sun
Jan 27, 2021·International Journal of Molecular Sciences·Dong-Soon Im
Jan 27, 2021·Nature Reviews. Endocrinology·Julien Ghislain, Vincent Poitout
Jan 16, 2021·Current Opinion in Endocrinology, Diabetes, and Obesity·Ming YangFiona M Gribble
Mar 19, 2020·Cell Metabolism·Ruth E GimenoRandy J Seeley
May 6, 2021·Nature Reviews. Endocrinology·Leigh PerreaultJulio Rosenstock
Jun 29, 2021·The Lancet. Diabetes & Endocrinology·Michael A NauckJuris J Meier
Jul 9, 2021·Cellular & Molecular Biology Letters·Jianan ZhaoJinghua Peng

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