Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes : A 24-week, multicentre, randomized, double-blind, placebo-controlled, phase III trial
© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd..
AIMS: To evaluate the efficacy and safety of a novel sodium-glucose cotransporter 2 inhibitor, enavogliflozin 0.3 mg monotherapy, in Korean people with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
MATERIALS AND METHODS: This study was a randomized, double-blind, placebo-controlled trial conducted in 23 hospitals. Individuals with haemoglobin A1c (HbA1c) of 7.0%-10.0% after at least 8 weeks of diet and exercise modification were randomized to receive enavogliflozin 0.3 mg (n = 83) or placebo (n = 84) for 24 weeks. The primary outcome was a change in HbA1c at week 24 from baseline. Secondary outcomes included the proportion of participants achieving HbA1c <7.0%, change in fasting glucose, body weight and lipid levels. Adverse events were investigated throughout the study.
RESULTS: At week 24, the placebo-adjusted mean change in HbA1c from baseline in the enavogliflozin group was -0.99% (95% confidence interval -1.24%, -0.74%). The proportions of patients achieving HbA1c <7.0% (71% vs. 24%) at week 24 was significantly higher in the enavogliflozin group (p < .0001). Placebo-adjusted mean changes in fasting plasma glucose (-40.1 mg/dl) and body weight (-2.5 kg) at week 24 were statistically significant (p < .0001). In addition, a significant decrease in blood pressure, low-density lipoprotein cholesterol, triglyceride, and homeostasis model assessment of insulin resistance were observed, along with a significant increase in high-density lipoprotein cholesterol. No significant increase in treatment-related adverse events was observed for enavogliflozin.
CONCLUSIONS: Monotherapy with enavogliflozin 0.3 mg improved glycaemic control in people with T2DM. Enavogliflozin therapy also exerted beneficial effects on body weight, blood pressure and lipid profile.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:25 |
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| Enthalten in: |
Diabetes, obesity & metabolism - 25(2023), 7 vom: 20. Juli, Seite 1865-1873 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kwak, Soo Heon [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 05.06.2023 Date Revised 06.06.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/dom.15046 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM353779504 |
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| 100 | 1 | |a Kwak, Soo Heon |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes |b A 24-week, multicentre, randomized, double-blind, placebo-controlled, phase III trial |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 05.06.2023 | ||
| 500 | |a Date Revised 06.06.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. | ||
| 520 | |a AIMS: To evaluate the efficacy and safety of a novel sodium-glucose cotransporter 2 inhibitor, enavogliflozin 0.3 mg monotherapy, in Korean people with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise | ||
| 520 | |a MATERIALS AND METHODS: This study was a randomized, double-blind, placebo-controlled trial conducted in 23 hospitals. Individuals with haemoglobin A1c (HbA1c) of 7.0%-10.0% after at least 8 weeks of diet and exercise modification were randomized to receive enavogliflozin 0.3 mg (n = 83) or placebo (n = 84) for 24 weeks. The primary outcome was a change in HbA1c at week 24 from baseline. Secondary outcomes included the proportion of participants achieving HbA1c <7.0%, change in fasting glucose, body weight and lipid levels. Adverse events were investigated throughout the study | ||
| 520 | |a RESULTS: At week 24, the placebo-adjusted mean change in HbA1c from baseline in the enavogliflozin group was -0.99% (95% confidence interval -1.24%, -0.74%). The proportions of patients achieving HbA1c <7.0% (71% vs. 24%) at week 24 was significantly higher in the enavogliflozin group (p < .0001). Placebo-adjusted mean changes in fasting plasma glucose (-40.1 mg/dl) and body weight (-2.5 kg) at week 24 were statistically significant (p < .0001). In addition, a significant decrease in blood pressure, low-density lipoprotein cholesterol, triglyceride, and homeostasis model assessment of insulin resistance were observed, along with a significant increase in high-density lipoprotein cholesterol. No significant increase in treatment-related adverse events was observed for enavogliflozin | ||
| 520 | |a CONCLUSIONS: Monotherapy with enavogliflozin 0.3 mg improved glycaemic control in people with T2DM. Enavogliflozin therapy also exerted beneficial effects on body weight, blood pressure and lipid profile | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
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| 650 | 7 | |a Cholesterol |2 NLM | |
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| 650 | 7 | |a Glycated Hemoglobin |2 NLM | |
| 650 | 7 | |a Hypoglycemic Agents |2 NLM | |
| 650 | 7 | |a Lipids |2 NLM | |
| 650 | 7 | |a Sodium-Glucose Transporter 2 Inhibitors |2 NLM | |
| 700 | 1 | |a Han, Kyung Ah |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Kyung-Soo |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Jae Myung |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, EunSook |e verfasserin |4 aut | |
| 700 | 1 | |a Won, Jong Chul |e verfasserin |4 aut | |
| 700 | 1 | |a Kang, Jun Goo |e verfasserin |4 aut | |
| 700 | 1 | |a Chung, Choon Hee |e verfasserin |4 aut | |
| 700 | 1 | |a Oh, Seungjoon |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Sung Hee |e verfasserin |4 aut | |
| 700 | 1 | |a Won, Kyu Chang |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Sin Gon |e verfasserin |4 aut | |
| 700 | 1 | |a Cho, Seung Ah |e verfasserin |4 aut | |
| 700 | 1 | |a Cho, Bo Young |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Kyong Soo |e verfasserin |4 aut | |
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