Insulin Aspart vs. Insulin Degludec/Liraglutide Dose Escalation Compared for Intensifying Type 2 Diabetes Treatment

For many individuals with Type 2 Diabetes Mellitus (T2DM), initial therapies like metformin and fixed-ratio combinations of basal insulin and GLP-1 receptor agonists, such as insulin degludec/liraglutide (IDegLira, Xultophy), eventually become insufficient to maintain glycemic control. As the disease progresses, patients often require further treatment intensification to prevent complications. The clinical challenge lies in determining the most effective and patient-friendly next step: whether to introduce a rapid-acting mealtime insulin or to simply increase the dose of an existing fixed-ratio combination. This trial addresses this critical gap in T2DM management strategies.

This global, randomized, controlled clinical trial aims to compare two distinct strategies for intensifying glycemic control in subjects with Type 2 Diabetes Mellitus. Participants were previously treated with insulin degludec/liraglutide and metformin, but required further therapeutic intervention due to inadequate glycemic control. The study design involves two treatment arms: one group receives sequential addition of insulin aspart, a rapid-acting insulin analog, while the comparator group undergoes a further dose increase with their existing insulin degludec/liraglutide combination. The primary objective is to assess the comparative efficacy and safety of these two intensification approaches, likely using HbA1c reduction as a key efficacy endpoint, consistent with other Phase 3 DUAL trials.