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A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients
Sae Jeong Yang1, Kyung Wan Min2, Sandeep Kumar Gupta3
1Department of Endocrinology, Daerim St. Mary's Hospital, Seoul, Korea.
Diabetes & Metabolism Journal
|October 21, 2020
Summary
Gemigliptin 50 mg demonstrated long-term efficacy and safety in type 2 diabetes mellitus (T2DM) patients over 52 weeks. Glycosylated hemoglobin (HbA1c) levels significantly decreased, with gemigliptin proving well-tolerated.
Area of Science:
- Endocrinology
- Pharmacology
Background:
- Type 2 diabetes mellitus (T2DM) is a global health concern requiring effective long-term management.
- Gemigliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor used for T2DM treatment.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of gemigliptin 50 mg in T2DM patients.
- To assess glycemic control and tolerability over a 52-week treatment period.
Main Methods:
- An open-label, 28-week extension study involving patients who completed an initial 24-week study.
- All participants received gemigliptin 50 mg, irrespective of prior treatment.
- Glycosylated hemoglobin (HbA1c) levels and adverse events were monitored.
Main Results:
- Gemigliptin treatment resulted in a sustained reduction in HbA1c levels at week 52.
- The mean HbA1c change from baseline was -0.9%±1.2% for the gemigliptin-gemigliptin group (P<0.0001).
- The mean HbA1c change from baseline was -0.7%±1.2% for the placebo-gemigliptin group (P<0.0001).
- Gemigliptin was found to be safe and well-tolerated up to 52 weeks, with a low incidence of adverse events.
Conclusions:
- Gemigliptin 50 mg provides long-term glycemic control in T2DM patients.
- The drug is safe and well-tolerated for extended use up to 52 weeks.
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