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
- Abstract
- 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.
- Author(s)
- Soo Heon Kwak; Kyung Ah Han; Kyung-Soo Kim; Jae Myung Yu; EunSook Kim; Jong Chul Won; Jun Goo Kang; Choon Hee Chung; Seungjoon Oh; Sung Hee Choi; Kyu Chang Won; Sin Gon Kim; Seung Ah Cho; Bo Young Cho; Kyong Soo Park
- Issued Date
- 2023
- Type
- Article
- DOI
- 10.1111/dom.15046
- URI
- https://oak.ulsan.ac.kr/handle/2021.oak/17453
- Publisher
- DIABETES OBESITY & METABOLISM
- Language
- 영어
- ISSN
- 1462-8902
- Citation Volume
- 25
- Citation Number
- 7
- Citation Start Page
- 1865
- Citation End Page
- 1873
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Appears in Collections:
- Medicine > Nursing
- 공개 및 라이선스
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