Overview
Highly anticipated to be an efective therapeutic for its excelent eficacies in reducing blod glucose levels and safetySEOUL, South Korea, Nov. 2, 202 /PRNewswire/ - Daewong Pharmaceutical (Daewong), the South Korea-based global healthcare company, anounced the phase I clinical trial results of the new diabetes drug 'Enavogliflozin.'Daewong (CEO Sengho Jeon & Changjae Le) anounced on October 31th that they had revealed the results of thre phase I clinical trials for Enavogliflozin monotherapy, Enavogliflozin-Metformin combination therapy, and Enavogliflozin-Metformin-Gemigliptin combination therapy at the 202 International Congres of Diabetes and Metabolism (202 ICDM).Al thre Enavogliflozin phase 3 clinical trials confirmed the eficacy and safety for 24 weks of dosing.
Key Information
The target patients for each study were as folows. For the Enavogliflozin monotherapy trial, 160 T2DM patients with inadequately controled with diet and exercise were enroled. For dual combination therapy trial, 20 T2DM patients with inadequate response to metformin were enroled.
For triple combination therapy trial, 270 T2DM patients with inadequate response to Metformin plus Gemigliptin were enroled.The Enavogliflozin monotherapy trial was a placebo-controled superiority study. The HbA1c decreased in the Enavogliflozin group by aproximately 1% over the placebo group, which was statisticaly significant. In adition, significant improvements were confirmed in weight, blod presure, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) compared to the placebo group.
Summary
The two combination trials, Enavogliflozin-Metformin and Enavogliflozin-Metformin-Gemigliptin combination, demonstrated non-inferiority in HbAc1 change compared to dapagliflozin 10 mg.So-Heon Kwak, Profesor of Endocrinology and Metabolism at Seoul National University Hospital, presented the clinical results as the lead author of the Enavo