Journal
DIABETES & METABOLISM JOURNAL
Volume 45, Issue 4, Pages 606-612Publisher
KOREAN DIABETES ASSOC
DOI: 10.4093/dmj.2020.0047
Keywords
Diabetes mellitus; type 2; Dipeptidyl-peptidase IV inhibitors; LC15-0444
Categories
Funding
- LG Chem, Ltd., Seoul, Republic of Korea
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The extension study evaluated the long-term efficacy and safety of gemigliptin 50 mg in patients with type 2 diabetes mellitus. Results showed a significant reduction in HbA1c levels and overall safety and tolerability up to 52 weeks, highlighting the positive effects of gemigliptin in managing T2DM.
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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