Chang Ho Ahn1, Kyung Ah Han2, Jae Myung Yu3, Joo Young Nam4, Kyu Jeung Ahn5, Tae Keun Oh6, Hyoung Woo Lee7, Dae Ho Lee8, Jaetaek Kim9, Choon Hee Chung10, Tae Sun Park11, Byung Joon Kim12, Seok Won Park13, Hyeong Kyu Park14, Kwang Jae Lee15, Sang-Wook Kim16, Jeong Hyun Park17, Kwan Pyo Ko18, Chong Hwa Kim19, Hyunjin Lee20, Hak Chul Jang21,22, Kyong Soo Park1,22,23. 1. Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. 2. Department of Internal Medicine, Eulji General Hospital, Seoul, Korea. 3. Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea. 4. Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea. 5. Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Seoul, Korea. 6. Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea. 7. Department of Internal Medicine, Yeungnam University Medical Centre, Daegu, Korea. 8. Department of Internal Medicine, Wonkwang University School of Medicine and Hospital, Iksan, Korea. 9. Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea. 10. Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea. 11. Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, Korea. 12. Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea. 13. Department of Internal Medicine, CHA Bundang Medical Center, Seongnam, Korea. 14. Department of Internal Medicine, Soonchunhyang University Hospital, Seoul, Korea. 15. Department of Internal Medicine, Daedong General Hospital, Busan, Korea. 16. Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea. 17. Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea. 18. Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea. 19. Department of Internal Medicine, Sejong General Hospital, Bucheon, Korea. 20. LG Life Sciences, Seoul, Korea. 21. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. 22. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. 23. Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea.
Abstract
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 withmetformin 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 withmetformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea.
RCT Entities:
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.
Authors: Min Kyong Moon; Kyu Yeon Hur; Seung Hyun Ko; Seok O Park; Byung Wan Lee; Jin Hwa Kim; Sang Youl Rhee; Hyun Jin Kim; Kyung Mook Choi; Nan Hee Kim Journal: Diabetes Metab J Date: 2017-10 Impact factor: 5.376
Authors: Eun Heui Kim; Sang Soo Kim; Dong Jun Kim; Young Sik Choi; Chang Won Lee; Bon Jeong Ku; Kwang Soo Cha; Kee Ho Song; Dae Kyeong Kim; In Joo Kim Journal: Sci Rep Date: 2020-11-04 Impact factor: 4.379