Efficacy and safety of monotherapy with enavogliflozin in Korean patients with type 2 diabetes mellitus: Results of a 12-week,multicentre, randomized,double-blind,placebo-controlled,phase 2 trial |
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| Authors: | Ye Seul Yang MD Kyung Wan Min MD Seok-O Park MD Kyung-Soo Kim MD Jae Myung Yu MD Eun-Gyoung Hong MD Sung Rae Cho MD Kyu Chang Won MD Yong Hyun Kim MD Seungjoon Oh MD Sung Hee Choi MD Gwanpyo Koh MD Wan Huh MS Su Young Kim MS Kyong Soo Park MD |
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| Affiliation: | 1. Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea;2. Department of Internal Medicine, Nowon Eulji Medical Center, Euji University School of Medicine, Seoul, South Korea;3. Gwangmyeong Sungae Hospital, Gwangmyeong, South Korea;4. Department of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, South Korea;5. Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea;6. Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, South Korea;7. Department of Internal Medicine, Changwon Fatima Hospital, Changwon, South Korea;8. Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea;9. Department of Internal Medicine, Bundang Jesaeng Hospital, Seongnam, South Korea;10. Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, South Korea;11. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea;12. Department of Internal Medicine, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, South Korea;13. Daewoong Pharmaceuticals, Seoul, South Korea |
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| Abstract: | Aims The study aimed to evaluate and compare the efficacy and safety of enavogliflozin, a newly developed sodium-glucose cotransporter 2 inhibitor, with placebo in Korean patients with type 2 diabetes mellitus. Materials and Methods Patients with glycated haemoglobin (HbA1c) of 7.0-10.0%, entered a 2-week placebo run-in period, and were randomized to receive once-daily enavogliflozin (0.1, 0.3 or 0.5 mg) or placebo for 12 weeks. The primary efficacy endpoint was the change in HbA1c from baseline at week 12. Results Overall, 194 patients were included in the full analysis set [placebo, n = 46; enavogliflozin (0.1 mg, n = 49; 0.3 mg, n = 50; 0.5 mg, n = 49)]. Patients receiving 0.1, 0.3 and 0.5 mg enavogliflozin showed significantly reduced HbA1c compared with those receiving placebo at week 12 (−0.79%, −0.89%, −0.92% and −0.08%, respectively; p < .001 vs. placebo). Mean changes in fasting plasma glucose from baseline at week 12 were −30.5, −31.1, −35.0 and 4.9 mg/dl in patients receiving enavogliflozin doses and placebo, respectively. The proportion of patients achieving HbA1c <7.0% at week 12 was significantly higher in the three enavogliflozin groups than in the placebo group (42.9%, 44.0%, 61.2% and 17.4%, respectively). A higher proportion of patients showed HbA1c reduction by >0.5% after receiving enavogliflozin doses than those receiving placebo (61.2%, 72.0%, 65.3% and 26.1%, respectively). There were no significant differences in incidences of adverse events of hypoglycaemia and genital infection between the groups. Conclusions Once-daily enavogliflozin monotherapy for 12 weeks is an effective, safe, and well-tolerated treatment for Korean patients with type 2 diabetes mellitus. |
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| Keywords: | enavogliflozin HbA1c sodium-glucose cotransporter 2 inhibitor type 2 diabetes |
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