NCT06408532

The Efficacy and Safety of Insulin Degludec/Liraglutide Combination (IDegLira) in Patients With Type 2 Diabetes

The Evaluation of the Efficacy and Safety of Switching to Once-daily IDegLira in Patients With Type 2 Diabetes Receiving Premixed Insulin Therapy, a Multi-center, Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the efficacy and safety of IDegLira in type 2 diabetes who have failed premixed insulin therapy. The study plans to enroll 256 participants with inadequate glycemic control despite twice-daily subcutaneous injections of premixed insulin and metformin. Participants will be randomly assigned to either the premixed insulin dose optimization group (control group) or IDegLira once daily group, and the difference in change in glycated hemoglobin levels from baseline to 16 weeks of treatment will be assessed between the two groups.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	IDegLira	The participants in this group will be switched to IDegLira once daily injection therapy.
DRUG	Premixed insulin	The participants in this group will be have optimized premixed insulin regimen.

Timeline

• Start date: 2024-04-30
• Primary completion: 2024-10-30
• Completion: 2025-02-28
• First posted: 2024-05-10
• Last updated: 2024-05-10

Regulatory

• FDA-regulated drug study