Aims: This multicentre, randomized, double-blind study investigated the efficacy and safety of gemigliptin in Korean type 2 diabetes mellitus (T2DM) patients with moderate to severe renal impairment (RI). Methods: The study comprised a 12-week main part and a 40-week extension. We report here the results from the main part. In total, 132 patients were randomized to receive gemigliptin (n = 66) or placebo (n = 66). Changes in glycated haemoglobin (HbA1c; primary endpoint), other glycaemic control parameters (fasting plasma glucose, glycated albumin and fructosamine), lipid profiles, renal function parameters and safety profiles were evaluated. Results: Baseline characteristics were comparable between the groups (mean HbA1c, 8.4% [68 mmol/mol]; age, 62.0 years; duration of type 2 diabetes, 16.3 years; estimated glomerular filtration rate, 33.3 mL/min/1.73 m2). At Week 12, the adjusted mean change ± standard error in HbA1c with gemigliptin was −0.82% ± 0.14% (−8.9 ± 1.5 mmol/mol), whereas it was 0.38% ± 0.14% (4.2 ± 1.5 mmol/mol) with placebo (significant between-group difference, P <.001). Other glycaemic control parameters showed beneficial changes as well. Body weight change (gemigliptin, −0.3 kg; placebo, −0.2 kg) was not significant. In the gemigliptin group, the mean decrease in urinary albumin creatinine ratio (UACR) was significant, both in patients with microalbuminuria (−41.9 mg/g creatinine, P =.03) and macroalbuminuria (−528.9 mg/g creatinine, P <.001). Drug-related adverse events were similar with gemigliptin and placebo (15% and 12%, respectively). Conclusions: A 12-week treatment with gemigliptin improved glycaemic control and provided UACR reduction in T2DM patients with moderate to severe RI. Gemigliptin was well tolerated, with no additional risk of hypoglycaemia and change in body weight.
Bibliographical noteFunding Information:
The authors thank the CRO (C&R Research Inc., Seoul, Republic of Korea) and staff for the conduct of the study, the patients for their participation, the industry sponsor (LG Life Sciences, Seoul, Republic of Korea) for coordination and funding of the study and Hye-Ryon Kim (Medical Writing, Inc.) for writing assistance. Y. H. J. and S. H. S. are LG Life Sciences employees. None of the other authors reported potential conflicts of interest relevant to this study. All authors participated in the design of the study. All authors except Y. H. J. and S. H. S. conducted the study and contributed toward acquisition of data. S. A. Y. wrote the manuscript. D. R. C. supervised the project and edited the manuscript. Y. H. J. and S. H. S. analysed the data. All authors reviewed and approved the final manuscript.
© 2016 John Wiley & Sons Ltd
All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism