drugset / Trial / NCT04965051
Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM
RandomizedParallel-groupOpen-labelTreatment
Summary
In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).
Timeline
- Start
- 2021-08
- Primary completion
- 2023-12
- Completion
- 2023-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin Lispro | Protein / enzyme biologic | — | — |
| Comparator | Insulin glulisine | Protein / enzyme biologic | — | — |
| Comparator | insulin aspart | Protein / enzyme biologic | — | — |
| Comparator | insulin degludec | Protein / enzyme biologic | — | — |
| Subject | insulin degludec/insulin aspart | Unknown | — | — |
| Comparator | insulin detemir | Protein / enzyme biologic | — | — |
| Comparator | insulin glargine | Protein / enzyme biologic | — | — |