The Phase 3 trial (NCT06559722) investigating insulin degludec/liraglutide injection for subjects with Type 2 Diabetes is expected to reach primary completion on October 31, 2025. This milestone indicates that data collection for the study's primary outcome measures is anticipated to conclude by this date.
Background
Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, and insulin degludec is a long-acting basal insulin. The combination of these two agents, such as in Xultophy® (insulin degludec and liraglutide), is used for the treatment of Type 2 Diabetes to improve glycemic control. This trial specifically focuses on the efficacy and safety of an insulin degludec/liraglutide injection in Chinese subjects with Type 2 Diabetes.
Trial design
The trial, identified as NCT06559722, is a Phase 3, randomized, open-label, multicenter, active-controlled, parallel-design study. It is designed to compare the efficacy and safety of Insulin Degludec/Liraglutide Injection with XULTOPHY® once daily via subcutaneous injection. The study is enrolling 510 participants diagnosed with Type 2 Diabetes. While the brief summary indicates a comparison of efficacy and safety, specific primary outcome measures were not detailed in the provided data.
What this means
The primary completion of this Phase 3 trial signifies a crucial step in the development of insulin degludec/liraglutide injection for Type 2 Diabetes in the Chinese population. Once primary completion is reached, researchers will focus on data analysis and interpretation, which will eventually lead to the public release of results. These results will provide important insights into the potential of this combination therapy as a treatment option for managing Type 2 Diabetes.
Source
Information regarding the primary completion date and trial details was sourced from ClinicalTrials.gov, a public database of clinical studies. The event for study NCT06559722, titled "A Trial Investigating the Efficacy and Safety of Insulin Degludec/Liraglutide Injection in Subjects With Type 2 Diabetes," is listed with an anticipated primary completion date of October 31, 2025 on clinicaltrials.gov.