Sun A Yoon1, Byoung G Han2, Sung G Kim3, Sang Y Han4, Young I Jo5, Kyung H Jeong6, Kook H Oh7, Hyeong C Park8, Sun H Park9, Shin W Kang, Ki R Na10, Sun W Kang11, Nam H Kim12, Young H Jang13, Seong H Shin13, Dae R Cha14. 1. Department of Internal Medicine, Catholic University Uijeongbu St. Mary's Hospital, Uijeongbu, Republic of Korea. 2. Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. 3. Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea. 4. Department of Internal Medicine, Inje University, Ilsan Paik Hospital, Goyang, Republic of Korea 5. Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea. 6. Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Republic of Korea. 7. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. 8. Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea. 9. Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea. 10. Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea. 11. Department of Internal Medicine, Busan Paik Hospital, Busan, Republic of Korea. 12. Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, Republic of Korea. 13. LG Life Sciences, Seoul, Republic of Korea. 14. Korea University Ansan-Hospital, Ansan, Republic of Korea.
Abstract
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.
RCT Entities:
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.
Authors: Juan Jose Garcia Sanchez; Juliette Thompson; David A Scott; Rachel Evans; Naveen Rao; Elisabeth Sörstadius; Glen James; Stephen Nolan; Eric T Wittbrodt; Alyshah Abdul Sultan; Bergur V Stefansson; Dan Jackson; Keith R Abrams Journal: Adv Ther Date: 2021-12-08 Impact factor: 3.845