A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus
- Author:
Sae Jeong YANG
1
;
Kyung Wan MIN
;
Sandeep Kumar GUPTA
;
Joong Yeol PARK
;
Vyankatesh K.SHIVANE
;
Pankaj Kumar AGARWAL
;
Doo Man KIM
;
Yong Esong KIM
;
Sei Hyun BAIK
Author Information
- Publication Type:Brief Report
- From:Diabetes & Metabolism Journal 2021;45(4):606-612
- CountryRepublic of Korea
- Language:English
- 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.
