Henagliflozin 5mg: Henagliflozin 5mg + lifestyle intervention
Henagliflozin 10mg: Henagliflozin 10mg+ lifestyle intervention
Placebo: Placebo+ lifestyle intervention
This clinical trial evaluates the effectiveness of Henagliflozin combined with lifestyle interventions for managing patients with prediabetes. As global prediabetes rates rise, increasing the risk of diabetes and vascular issues, addressing treatment gaps is essential. Henagliflozin, a novel SGLT2 inhibitor developed in China, aims to improve glucose control and metabolic health when paired with lifestyle changes.
The study's primary objectives include: assessing whether Henagliflozin can achieve normoglycemia in prediabetic patients after 6 months of treatment.
The trial will compare three groups (Henagliflozin 5mg, 10mg, and a placebo), focusing on efficacy and safety. Participants, assigned randomly, will undergo a 6-month treatment phase and an 18-month follow-up. Regular health assessments will monitor glucose levels, metabolic health, and risks of major complications like cardiovascular events and microvascular diseases, with additional evaluations of C-peptide and insulin changes.
Structured as a multicenter, randomized, double-blind, placebo-controlled study, it involves 984 prediabetic adults across 50 medical institutions in China. This comprehensive approach could redefine prediabetes management by integrating drug therapy with lifestyle modifications.
| Facility | City | Region | Status |
|---|---|---|---|
| Chuzhou First People's Hospital | Chuzhou | Anhui | |
| The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui | |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | |
| Fujian Provincial Hospital | Fuzhou | Fujian | |
| LanZhou University | Lanzhou | Gansu | |
| Shunde Hospital of Southern Medical University | Foshan | Guangdong | |
| Southern Medical University | Guangzhou | Guangdong | |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guanzhou | Guangdong | |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | |
| First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | |
| North China University of Technology Affiliated Hospital | Tangshan | Hebei | |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | |
| Xinyang Central Hospital | Xinyang | Henan | |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | |
| Tongji Hospital | Wuhan | Hubei | |
| Xiangyang Central Hospital | Xiangyang | Hubei | |
| Xiangya Hospital of Central South University | Changsha | Hunan | |
| The Second Affiliated Hospital of Baotou Medical College | Baotou | Inner Mongolia | |
| Second Affiliated Hospital of Nanchang University | Nanchang | Jiangsu | |
| The First Affiliated Hospital with Nanjing Medical University, | Nanjing | Jiangsu | |
| Wuxi People's Hospital | Wuxi | Jiangsu | |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | |
| The First Hospital of Jilin University | Changchun | Jilin | |
| First Affiliated Hospital of China Medical University | Shenyang | Liaoning | |
| People's Hospital of Liaoning Province | Shenyang | Liaoning | |
| Ningxia Medical University | Yinchuan | Ningxia | |
| Binzhou City Central Hospital | Binzhou | Shandong | |
| Dongying People's Hospital | Dongying | Shandong | |
| Jinan Central Hospital | Jinan | Shandong | |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | |
| Liaocheng People's Hospital | Liaocheng | Shandong | |
| The Second Affiliated Hospital of Shandong First Medical University | Tai’an | Shandong | |
| The Affiliated Hospital of Weifang Medical University | Weifang | Shandong | |
| Weifang People's Hospital | Weifang | Shandong | |
| Yantai Affiliated Hospital of Binzhou Medical University | Yantai | Shandong | |
| Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan | |
| First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | |
| The Central Hospital of Lishui City | Lishui | Zhejiang | |
| First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
+ 10 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06448130 on ClinicalTrials.gov ↗ ← All trials in China