Results
Title

A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus.

Authors

Sae Jeong Yang; Kyung Wan Min; Gupta, Sandeep Kumar; Joong Yeol Park; Shivane, Vyankatesh K.; Agarwal, Pankaj Kumar; Doo Man Kim; Yong Seung Kim; Sei Hyun Baik

Abstract

The purpose of this extension study was to assess the long-term efficacy and safety of gemigliptin 50 mg in patients with type 2 diabetes mellitus (T2DM). Patients with T2DM who had completed the initial 24-week study comparing gemigliptin monotherapy with placebo were eligible to enrol. In the open-label, 28-week extension study, all enrolled patients received gemigliptin, regardless of the treatment received during the initial 24-week study period. The mean reduction±standard deviation (SD) in glycosylated hemoglobin (HbA1c) observed after 24 weeks of treatment (-0.6%±1.1%) was further decreased for the gemi-gemi group and the mean change in HbA1c at week 52 from baseline was -0.9%±1.2% (P<0.0001). For the pbo-gemi group, HbA1c decreased after they were switched to gemigliptin, and the mean change in HbA1c at week 52 from baseline was -0.7%±1.2% (P<0.0001). Furthermore, the overall incidence of adverse events demonstrated that gemigliptin was safe and well tolerated up to 52 weeks.

Subjects

TYPE 2 diabetes; GLYCOSYLATED hemoglobin

Publication

Diabetes & Metabolism Journal, 2021, Vol 45, Issue 4, p606

ISSN

2233-6079

Publication type

Academic Journal

DOI

10.4093/dmj.2020.0047