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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Recruitment opened
    • Trial sites expanded: 0 → 24 locations
    • Start date changed from estimate of Dec 15, 2025 to Dec 13, 2025
    • Eligibility criteria shortened, about 6 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07307235
Lead Sponsor Shanghai Zhongshan Hospital
Collaborators: Sanofi (China) Investment Co., Ltd
Conditions
(from sponsor)		 Type 2 Diabetes
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 2
Enrollment 1,316 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov