NCT05417841

Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T2DM

A Multicenter, Randomized, Open, Parallel-controlled Clinical Trial to Compare the Efficacy and Safety of IDegAsp BID and IDegAsp QD+2IAsp in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared with IDegAsp once daily plus IAsp twice daily for 16 weeks in patients with type 2 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 2 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 224 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or IDegAsp + IAsp group. Duration of treatment includes 3-week screening period, 16-week treatment observation period and 1-week follow-up.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin Degludec and Insulin Aspart Injection	To evaluate the efficacy and safety of the IDegAsp BID in T2DM
DRUG	Insulin Aspart Injection	To evaluate the efficacy and safety of the IDegAsp QD plus IAsp BID in T2DM

Timeline

• Start date: 2023-03-23
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2022-06-14
• Last updated: 2025-12-03

Locations

7 sites across 1 country: China