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Peer-reviewedCC BY-NC-NDJournal of diabetes investigation

Real-world effectiveness and safety of enavogliflozin in patients with type 2 diabetes: A 24-week prospective multicenter observational study in Korea.

  • Hyunji Sang1,2
  • Yeongtaek Hwang2,3
  • Selin Woo2
  • Soo Jin Yun1
  • Meehoh Kim2
  • Ho Geol Woo2,4
  • Joo Young Kim5
  • Dong Keon Yon2,3,6,7,8
  • Sang Youl Rhee1,2,3,6
8 affiliations
  1. 1Department of Endocrinology and Metabolism, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.
  2. 2Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.
  3. 3Department of Precision Medicine, Kyung Hee University College of Medicine, Seoul, South Korea.
  4. 4Department of Neurology, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.
  5. 5Gangnam Endo Clinic, Seoul, South Korea.
  6. 6Department of Regulatory Science, Kyung Hee University, Seoul, South Korea.
  7. 7Department of Biomedical Engineering, Kyung Hee University, Yongin, South Korea.
  8. 8Department of Pediatrics, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.
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Abstract

Aims/introduction

To evaluate the real-world effectiveness and safety of enavogliflozin as a single-pill formulation (Enavo group; enavogliflozin 0.3 mg) or fixed-dose combination with metformin (EnavoMet group; enavogliflozin 0.3 mg/metformin 1000 mg) in patients with type 2 diabetes (T2DM) in Korean primary care.Materials and methods

This prospective, multicenter, non-interventional observational study enrolled 8796 adults with type 2 diabetes mellitus from 273 primary care clinics across Korea (Safety Set). The full analysis set comprised 8704 participants (Enavo: 7046; EnavoMet: 1658) with baseline and at least one post-baseline glycated hemoglobin (HbA1c) measurement. The primary endpoint was HbA1c change at 24 weeks.Results

At 24 weeks, mean HbA1c decreased by -0.69 percentage points (95% CI: -0.71, -0.67) in Enavo (n = 7003) and -0.86 (-0.90, -0.82) in EnavoMet (n = 1648). In these paired cohorts, 1728 (24.7%) and 371 (22.5%), respectively, already had HbA1c <7.0% at baseline. Overall 24-week HbA1c <7.0% rates were 61.6% and 63.6%, combining maintenance and new attainment; <6.5% rates were 30.0% and 37.2%. Weight and systolic blood pressure decreased (-2.43/-2.73 kg; -3.05/-3.77 mmHg). Adverse events were recorded in 39 participants (0.44%); no serious events were recorded.Conclusions

Enavogliflozin use was associated with decreases in HbA1c, body weight, and blood pressure over 24 weeks. Overall target rates include participants already below target at baseline and do not establish causal treatment effects.

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Cite

BibTeXRIS
BibTeX
@article{sang2026realworld,
  title = {{Real-world effectiveness and safety of enavogliflozin in patients with type 2 diabetes: A 24-week prospective multicenter observational study in Korea.}},
  author = {Hyunji Sang and Yeongtaek Hwang and Selin Woo and Soo Jin Yun and Meehoh Kim and Ho Geol Woo and Joo Young Kim and Dong Keon Yon and Sang Youl Rhee},
  journal = {Journal of diabetes investigation},
  year = {2026},
  month = oct,
  doi = {10.1111/jdi.70478},
  url = {https://europepmc.org/article/MED/42952084},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Real-world effectiveness and safety of enavogliflozin in patients with type 2 diabetes: A 24-week prospective multicenter observational study in Korea.
AU  - Hyunji Sang
AU  - Yeongtaek Hwang
AU  - Selin Woo
AU  - Soo Jin Yun
AU  - Meehoh Kim
AU  - Ho Geol Woo
AU  - Joo Young Kim
AU  - Dong Keon Yon
AU  - Sang Youl Rhee
PY  - 2026
DA  - 2026/10/28
JO  - Journal of diabetes investigation
DO  - 10.1111/jdi.70478
UR  - https://europepmc.org/article/MED/42952084
AB  - Aims/introduction  To evaluate the real-world effectiveness and safety of enavogliflozin as a single-pill formulation (Enavo group; enavogliflozin 0.3 mg) or fixed-dose combination with metformin (EnavoMet group; enavogliflozin 0.3 mg/metformin 1000 mg) in patients with type 2 diabetes (T2DM) in Korean primary care.Materials and methods  This prospective, multicenter, non-interventional observational study enrolled 8796 adults with type 2 diabetes mellitus from 273 primary care clinics across Korea (Safety Set). The full analysis set comprised 8704 participants (Enavo: 7046; EnavoMet: 1658) with baseline and at least one post-baseline glycated hemoglobin (HbA1c) measurement. The primary endpoint was HbA1c change at 24 weeks.Results  At 24 weeks, mean HbA1c decreased by -0.69 percentage points (95% CI: -0.71, -0.67) in Enavo (n = 7003) and -0.86 (-0.90, -0.82) in EnavoMet (n = 1648). In these paired cohorts, 1728 (24.7%) and 371 (22.5%), respectively, already had HbA1c <7.0% at baseline. Overall 24-week HbA1c <7.0% rates were 61.6% and 63.6%, combining maintenance and new attainment; <6.5% rates were 30.0% and 37.2%. Weight and systolic blood pressure decreased (-2.43/-2.73 kg; -3.05/-3.77 mmHg). Adverse events were recorded in 39 participants (0.44%); no serious events were recorded.Conclusions  Enavogliflozin use was associated with decreases in HbA1c, body weight, and blood pressure over 24 weeks. Overall target rates include participants already below target at baseline and do not establish causal treatment effects.
SN  - 2040-1116
SN  - 2040-1124
ER  -