Effectiveness and Safety of Fixed-Dose Combination Metformin and Empagliflozin in Type 2 Diabetes: A Prospective,...

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).

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).

A total of 2602 adults with T2DM were enrolled. The full-analysis sets included 1719 patients, respectively. Median age was 54 years, median body mass index (BMI) was 25.7 kg/m², 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.

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.