In the era of evidence-based medicine, randomized controlled trials (RCTs) provide robust evidence for new drug approval, while real-world evidence (RWE) helps reveal the actual performance of drugs in complex and diverse clinical settings. Since its global launch, insulin degludec/insulin aspart has not only demonstrated favorable efficacy and safety in registration trials but also continues to validate its clinical value in the broad real-world practice. Recently, Professor Zhang Jie from Beijing Hospital published an article entitled “Post-Marketing Review of Insulin Degludec/Insulin Aspart: Real-World Evidence from Multiple Countries Worldwide”, which summarized real-world data from domestic and international sources and served as an effective supplement to RCTs.
The value of an innovative drug truly emerges when it enters clinical practice. As a “dual insulin” combining long-acting stability and rapid-acting flexibility, insulin degludec/insulin aspart has pharmacological characteristics that enable simplified treatment and optimized glycemic control. However, clinical trial findings must ultimately be verified in real-world settings. The review published by Professor Zhang Jie from the National Center for Geriatrics, Beijing Hospital, represents a cross-border scientific overview. Instead of being limited to data silos from single centers, it integrated real-world study results from tens of thousands of patients across China, Europe, Asia, North America and other regions.
The CREATE study is the first nationwide real-world study of insulin degludec/insulin aspart in China, led by Professor Guo Lixin from Beijing Hospital. It enrolled 878 adult patients with type 2 diabetes mellitus (T2DM) who initiated or switched treatment from various background therapies including oral antidiabetic drugs (OADs), basal insulin, premixed insulin, and GLP-1 RA ± insulin, with a 20-week observation period. Results showed that overall HbA1c decreased from 8.95% to 7.69%, with a reduction of 1.27%; the OAD subgroup achieved the greatest reduction (–2.01%). Mean fasting plasma glucose decreased by 1.61 mmol/L, and the rate of non-severe hypoglycemia was reduced by 60%. This study provided the first high-quality real-world evidence confirming the efficacy and safety of insulin degludec/insulin aspart in broad clinical practice in China, filling the gap in local data.
Several RCTs (including the ONISHI study, STEP BY STEP study, BOOST JAPAN study, BOOST CHINA study, BOOST®: SIMPLE USE study, INTENSIFY PREMIXI I study) have previously confirmed the favorable efficacy of insulin degludec/insulin aspart. Since its launch, more than 10 real-world studies have been conducted overseas in patients with T2DM and type 1 diabetes mellitus (T1DM), further verifying its efficacy and safety from various perspectives. Evidence shows that insulin degludec/insulin aspart can be used for initial therapy or as a switch from other regimens to further improve glycemic control.
Therefore, insulin degludec/insulin aspart has demonstrated highly consistent clinical performance across Caucasian, Asian, Latin American and other ethnic populations and healthcare settings, providing a solid scientific foundation for its widespread global application.