drugset / Trial / NCT05417841
Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T2DM
RandomizedParallel-groupOpen-labelTreatment
Summary
In this multicenter, randomized, open-label, parallel-controlled, non-inferiority clinical trial, the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with degludec/insulin aspart (IDegAsp) once daily plus insulin aspart (IAsp) twice daily after 16weeks of treatment in patients with type 2 diabetes mellitus. This trial will enable primary assessment of the clinically relevant endpoint of a change in HbA1c.
Timeline
- Start
- 2023-03-23
- Primary completion
- 2025-08-15
- Completion
- 2025-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | insulin aspart | Protein / enzyme biologic | — | — |
| Subject | insulin degludec | Protein / enzyme biologic | — | — |