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KMID : 1200020210450040606
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Diabetes & Metabolism Journal
2021 Volume.45 No. 4 p.606 ~ p.612
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A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus
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Yang Sae-Jeong
Min Kyung-Wan
Gupta Sandeep Kumar
Park Joong-Yeol
Shivane Vyankatesh K.
Agarwal Pankaj Kumar
Kim Doo-Man
Kim Yong-Seung
Baik Sei-Hyun
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Abstract
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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.
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KEYWORD
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Diabetes mellitus, type 2, Dipeptidyl-peptidase IV inhibitors, LC15-0444
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