Daewoong's Enavogliflozin Hits 88% Enrollment in SGLT-2 Inhibitor Head-to-Head Trial

Daewoong Pharmaceutical is accelerating a clinical trial that directly compares Enblo, a Korean-developed diabetes drug, with sodium-glucose cotransporter-2 (SGLT-2) inhibitors. As a study confirming the integrated cardiovascular, renal, and metabolic management effects in Asian patients in a real-world clinical setting, the company aims to secure evidence for expanding prescriptions going forward.

Daewoong Pharmaceutical said on the 4th that it disclosed the interim analysis results and progress of Enblo's "ENVELOP" clinical study at the 39th Spring Conference of the Korean Diabetes Association, held from April 30 to May 2 at the Kimdaejung Convention Center in Gwangju. The ENVELOP study is a large-scale domestic multicenter study led by Professor Kim Shin-gon's research team at the Department of Endocrinology, Korea University College of Medicine. It was designed to confirm how effective Enblo, Korea's 36th domestically developed new drug, is in preventing cardiovascular disease and improving kidney function in Asian diabetes patients in actual clinical practice.

The distinguishing feature of this study is its head-to-head comparison method between SGLT-2 inhibitors. Existing global large-scale cardiovascular clinical studies were mainly conducted using placebo controls, which had limitations in comparing the superiority among drugs within the same class. Accordingly, the ENVELOP study verified non-inferiority by comparing Enblo with dapagliflozin and empagliflozin.

The study is being conducted as a pragmatic clinical trial involving endocrinology medical staff at 55 institutions across Korea. Rather than a strictly controlled environment, it is structured to secure clinical evidence by reflecting data from actual clinical practice. As of April this year, approximately 88% of the target 2,862 patients had been enrolled. The average age of enrolled patients is 60.4 years, with an average body mass index of 26.26 kg/㎡.

The interim analysis showed that changes in key indicators—glycated hemoglobin (HbA1c), estimated glomerular filtration rate (eGFR), and urine albumin-to-creatinine ratio (UACR)—did not show significant differences from the control group. In terms of safety, no serious adverse drug reactions were reported. Daewoong Pharmaceutical expects that this study will allow it to secure evidence for Asian patients that is differentiated from existing clinical data centered on Westerners.

Kim Shin-gon, professor of endocrinology at Korea University College of Medicine, explained, "Through this study, we will be able to secure long-term evidence for Asian patients and promote the status of K-medicine." Park Hyung-chul, head of Daewoong Pharmaceutical's ETC Marketing Division, stressed, "As the world's first head-to-head comparison data between SGLT-2 inhibitors, it will become an academic asset that can change the standards for treatment selection in Korea."