Effectiveness and Safety of Fixed‐Dose Combination Metformin and Empagliflozin in Type 2 Diabetes: A Prospective, Multicenter, Real‐World Study From China
Abstract
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.
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Authors: Weijian Ke, Yinghong Kong, Fu Songbo, Liyun Wang, Ying Pan, Shao Zhong, Yanhua Jiang, Hui Chen, Xuehua Jiao, Fuxing Sha, Liwu Xu, Wei Shao, Fenghua Lan, Xiaoli Chen, Bo Yan, Guangju Zhou, Ping Shi, Fen Li, Huike He, Li Hong, Guangwu Zhang, Hongyu Duan, Fang Wang, Weikun Gong, Yuxiao Bai, Bin Wang, Xin Mou, Liying He, Wukun Ma, Junhua Song, Juan Zheng, Xiaosu Bai, Xiaosi Li, Xin Yan, Yanqiu Wang, Zhenhua Wang, Juan Yuan, Wei Lu, Yuan Liang, Yufan Wang, Fenjuan Xu, Xuefeng Li, Xuan Lin, Hongbin Zhu, Lingling Xu, Xiaojia Lou, Lingxiao Wang, 崔丽娟, Lijun Wang, Hua Qian, Yuwen Shi, Yanbing Li
Institutions: Ningbo University, Shanghai Jiao Tong University, Hebei Medical University, Ningbo University Affiliated Hospital, Sun Yat-sen University, Southern Medical University, Soochow University, Zhangjiagang First People's Hospital, Lanzhou University, Xuzhou Medical College, Lanzhou University Second Hospital, Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine, The First Affiliated Hospital, Sun Yat-sen University, Nantong University, Taizhou Second People's Hospital, Guangxi Medical University, Southern Medical University Shenzhen Hospital, Wenzhou Medical University, Henan University of Science and Technology, Jiangsu University, Xian Central Hospital, Shaoxing People's Hospital, Affiliated Hospital of North Sichuan Medical College, First Hospital of Lanzhou University, Huainan Normal University, Xingtai People's Hospital, Ningbo Medical Center Lihuili Hospital, Anhui University of Science and Technology, Yixing People's Hospital, Wuhan Sixth Hospital, Huaian First People’s Hospital, The First People's Hospital of Changde, Central Hospital of Zibo, Affiliated Hospital of Shaanxi University of Chinese Medicine, Shanghai First People's Hospital, First Hospital of Jiaxing, Shaoxing Second Hospital, Taizhou First People's Hospital, ShenZhen People’s Hospital, First People's Hospital of Kunshan, Dongyang People's Hospital, Kaifeng University, Kaifeng City Children's Hospital, Jiangxi Pingxiang People's Hospital, The Second Affiliated Hospital of Bengbu Medical College, Hangzhou Red Cross Hospital, The First People's Hospital of Guiyang, Changshu No. 2 People's Hospital, Fourth Hospital of Changsha, The Fourth People's Hospital of Zibo City