Effectiveness and Safety of Fixed‐Dose Combination Metformin and Empagliflozin in Type 2 Diabetes: A Prospective, Multicenter, Real‐World Study From China
BACKGROUND: This study assessed the real-world effectiveness and safety of a fixed-dose combination (FDC) of metformin and empagliflozin in Chinese patients with type 2 diabetes mellitus (T2DM). METHODS: This prospective, multicenter, real-world study enrolled consecutive patients with T2DM treated with the FDC of metformin and empagliflozin between August 2023 and August 2025 across 50 clinical centers in China. The primary endpoint was the 6-month glycemic clinical control rate (HbA1c < 7.0%). The safety outcome included adverse events (AEs), major adverse cardiovascular events (MACEs), and major adverse kidney events (MAKEs). RESULTS: , median HbA1c was 8.3%, and median diabetes duration was 3 years; 34% of patients were female. At 6 months, the proportion of patients achieving HbA1c < 7.0% increased from 20.2% to 58.9%, with median HbA1c falling by about 1.1%-1.2%. Treatment also lowered fasting plasma glucose, body weight, and waist and hip circumference, and modestly reduced blood pressure, improving blood pressure control and shifting the BMI distribution toward normal weight. Subgroup analyses showed higher HbA1c target attainment in younger patients, those with lower baseline HbA1c, and those with higher BMI. Most patients remained on metformin/empagliflozin. AEs, MACEs, MAKEs, ketoacidosis, and genitourinary infections were infrequent. CONCLUSION: In this large-scale, real-world study in a Chinese population, the empagliflozin and metformin FDC improved long-term HbA1c control and was well tolerated.
Authors
- Xiaojia Lou
- Guangju Zhou
- Xiaosu Bai
- Weijian Ke (ORCID: https://orcid.org/0000-0002-5158-2245)
- Xuehua Jiao
- Li Hong
- Liwu Xu (ORCID: https://orcid.org/0009-0004-3489-4169)
- Yuwen Shi (ORCID: https://orcid.org/0009-0009-7228-0420)
- Shao Zhong (ORCID: https://orcid.org/0000-0002-9054-6554)
- 崔丽娟
- Hua Qian
- Ying Pan (ORCID: https://orcid.org/0000-0001-9935-6194)
- Xuefeng Li (ORCID: https://orcid.org/0000-0001-9671-2616)
- Weikun Gong
- Yanbing Li (ORCID: https://orcid.org/0000-0003-3782-9210)
- Lingling Xu (ORCID: https://orcid.org/0000-0003-2731-4758)
- Xin Yan (ORCID: https://orcid.org/0000-0003-0482-3314)
- Yuan Liang
- Fenjuan Xu
- Xuan Lin (ORCID: https://orcid.org/0000-0002-7272-7271)
- Fu Songbo
- Liyun Wang
- Juan Yuan
- Wei Lu
- Junhua Song
- Lijun Wang
- Fenghua Lan
- Bo Yan
- Wukun Ma
- Hongbin Zhu
- Yuxiao Bai
- Huike He
- Lingxiao Wang
- Hui Chen
- Yanhua Jiang
- Guangwu Zhang
- Xiaosi Li
- Yinghong Kong
- Yanqiu Wang
- Yufan Wang
- Juan Zheng
- Fang Wang
- Bin Wang
- Fen Li
- Ping Shi
- Fuxing Sha
- Liying He
- Hongyu Duan
- Xiaoli Chen
- Wei Shao
- Xin Mou
- Zhenhua Wang
Institutions
- Ningbo University (CN)
- Hebei Medical University (CN)
- Jiangsu University (CN)
- Sun Yat-sen University (CN)
- Guangxi Medical University (CN)
- Henan University of Science and Technology (CN)
- Xuzhou Medical College (CN)
- Shanghai Jiao Tong University (CN)
- Anhui University of Science and Technology (CN)
- Nantong University (CN)
- Wenzhou Medical University (CN)
- Soochow University (CN)
- Xian Central Hospital (CN)
- The Fourth People's Hospital of Zibo City (CN)
- Taizhou Second People's Hospital (CN)
- Huaian First People’s Hospital (CN)
- Kaifeng University (CN)
- ShenZhen People’s Hospital (CN)
- Zhangjiagang First People's Hospital (CN)
- Affiliated Hospital of North Sichuan Medical College (CN)
- First People's Hospital of Kunshan (CN)
- Fourth Hospital of Changsha (CN)
- Ningbo Medical Center Lihuili Hospital (CN)
- Shaoxing Second Hospital (CN)
- Xingtai People's Hospital (CN)
- Jiangxi Pingxiang People's Hospital (CN)
- The First People's Hospital of Changde (CN)
- Lanzhou University Second Hospital (CN)
- The First Affiliated Hospital, Sun Yat-sen University (CN)
- Shanghai First People's Hospital (CN)
- Huainan Normal University (CN)
- Kaifeng City Children's Hospital (CN)
- Affiliated Hospital of Shaanxi University of Chinese Medicine (CN)
- First Hospital of Jiaxing (CN)
- Yixing People's Hospital (CN)
- The Second Affiliated Hospital of Bengbu Medical College (CN)
- Southern Medical University Shenzhen Hospital (CN)
- The First People's Hospital of Guiyang (CN)
- Taizhou First People's Hospital (CN)
- Wuhan Sixth Hospital (CN)
- Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine (CN)
- Hangzhou Red Cross Hospital (CN)
- Central Hospital of Zibo (CN)
- Ningbo University Affiliated Hospital (CN)
- Dongyang People's Hospital (CN)
- Shaoxing People's Hospital (CN)
- First Hospital of Lanzhou University (CN)
- Changshu No. 2 People's Hospital
- Southern Medical University (CN)
- Lanzhou University (CN)
Publication Details
- Journal
- Journal of Diabetes
- Published
- 2026-09-28
- DOI
- https://doi.org/10.1111/1753-0407.70273
- Primary Topic
- Diabetes Treatment and Management
- Type
- article
- Field-Weighted Citation Impact
- 0.00