NCT07307235

Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents

Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents-a Pragmatic Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,316 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, multicenter, parallel-group, positive-controlled, and pragmatic randomized clinical trial (pRCT). It will compare the efficacy and safety of iGlarLixi versus standard of care in adult T2DM patients with poor glycemic control, who are using 1 to 3 OADs in a real-world clinical practice setting. A total of 1,316 subjects from approximately 40 research centers in China will be randomly assigned in a 1:1 ratio to one of the following treatment groups: Group 1: iGlarLixi for blood glucose control; and Group 2: Standard of care for diabetes (basal insulin or premixed insulin, excluding any GLP-1RA-containing drugs). Considering the substantial difference in intervention methods between the two groups, the study is designed as non-blinded with an open-label approach.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	iGlarLixi (insulin glargine/lixisenatide)	The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as intensification therapy in routine clinical practice.
DRUG	standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)	The control drug treatment is standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs). Participants will receive standard of care with the OAD treatment regimen being maintained or appropriately adjusted as an intensification treatment during routine clinical practice.

Timeline

• Start date: 2025-12-15
• Primary completion: 2027-06-30
• Completion: 2027-12-30
• First posted: 2025-12-29
• Last updated: 2025-12-29