Aims: To assess the efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, added to metformin and sulphonylurea in patients with type 2 diabetes (T2DM). Materials and methods: We conducted a randomized, double-blind, placebo-controlled trial in 219 Korean patients inadequately controlled with metformin and glimepiride. Participants were randomized to gemigliptin 50 mg once daily or placebo added to metformin and glimepiride. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Results: The baseline HbA1c was 8.2% in both groups. The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between-group difference in adjusted mean change −0.87%, 95% confidence interval [CI] −1.09% to −0.64%). Fasting plasma glucose level was also significantly reduced with gemigliptin (−0.93 mmol/L, 95% CI −1.50 to −0.35 mmol/L), and a higher proportion of participants achieved an HbA1c level of <7% (39.3% vs 5.5%; P <.001) in the gemigliptin group than in the placebo group. Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (−0.21 mmol/L, 95% CI −0.38 to −0.03 mmol/L for total cholesterol, −0.18 mmol/L, 95% CI −0.34 to −0.01 mmol/L for LDL cholesterol). The incidence of hypoglycaemia was 9.4% in the gemigliptin group and 2.7% in the placebo group. Conclusions: Gemigliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea.
Bibliographical noteFunding Information:
The study was funded by LG Life Sciences Ltd., Seoul, Korea. H. L. is an employee of LG Life Sciences, Ltd. None of the other authors have potential conflicts of interest relevant to this study. C.H.A. analysed and interpreted the data, and drafted the manuscript. K.A.H., J.M.Y, J.Y.N., K.J.A., T.K.O., H.W.L., D.H.L., J.K., C.H.C., T.S.P., B.J.K., S.W.P., H.K.P., K.J.L., S.W.K., J.H.P., K.P.K., and C.H.K. recruited the subjects and collected the data. L.H.L participated in the statistical planning and analysed the data. H.C.J. contributed to the design of the study, recruited the subjects, and collected the data. K.S.P. designed the study, recruited the subjects, collected the data and revised the manuscript. All authors approved the final manuscript as submitted.
© 2016 John Wiley & Sons Ltd
All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism