Daewoong Pharmaceutical’s novel diabetes drug Envlo (inavogliflozin) has demonstrated blood sugar and kidney function improvement effects comparable to existing treatments in a groundbreaking head-to-head clinical study of SGLT-2 inhibitors.
The company revealed interim analysis results and the latest progress of the ENVELOP clinical study at the 39th Spring Conference of the Korean Diabetes Association in Gwangju on Thursday.
Envlo, the 36th domestically developed new drug by Daewoong Pharmaceutical, is an SGLT-2 inhibitor that treats diabetes by blocking glucose reabsorption in the kidneys, promoting its excretion through urine.
The ENVELOP study, spearheaded by Professor Kim Shin-gon from Korea University’s Department of Endocrinology, involves a multi-institutional research team across Korea. It aims to verify Envlo’s effectiveness in preventing cardiovascular disease and improving kidney function in real-world clinical settings.
This study marks a global first in directly comparing SGLT-2 inhibitors, assessing Envlo’s non-inferiority against established drugs like dapagliflozin and empagliflozin.
Previously, the cardiovascular and renal protective effects of SGLT-2 inhibitors were mainly proven through placebo-controlled trials. The lack of direct comparisons between drugs in the same class has made this study a focal point of industry interest.
The ongoing multi-center, prospective clinical trial involves 55 Korean institutions. As of April, about 88% of the targeted 2,862 patients have been enrolled, with an average age of 60.4 years and a mean body mass index (BMI) of 26.26 kg/m² (about 5.38 lb/ft²).
Interim analysis shows no significant differences in key metrics – hemoglobin A1c (HbA1c), estimated glomerular filtration rate (eGFR), and urine albumin-to-creatinine ratio (UACR) – compared to the control group. The absence of serious adverse drug reactions (SADRs) further confirms the drug’s excellent tolerability.
The study’s pragmatic trial design, reflecting real-world clinical data, adds to its significance. Unlike previous Western-centric global trials, this study focuses on Korean and Asian patients with an average BMI of about 26 kg/m² (about 5.33 lb/ft²), potentially informing future treatment approaches for Asian populations.
Park Hyung-cheol, head of Daewoong Pharmaceutical’s ETC Marketing Division, emphasized the study’s importance in establishing clinical evidence for Envlo based on real-world data. He anticipates it will become a crucial academic resource, potentially influencing diabetes treatment guidelines in Korea.