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.
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.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of USTC / Anhui Provincial Hospital | Hefei | Anhui | Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | Recruiting |
| The First People's Hospital of Huizhou | Huizhou | Guangdong | Recruiting |
| Shenzhen Third People's Hospital | Shenzhen | Guangdong | Recruiting |
| Heilongjiang Provincial Hospital | Harbin | Heilongjiang | Recruiting |
| Xinxiang Central Hospital | Xinxiang | Henan | Recruiting |
| Wuhan Fourth Hospital / Wuhan Puai Hospital | Wuhan | Hubei | Recruiting |
| Hunan Provincial People's Hospital / The First Affiliated Hospital of Hunan Normal University | Changsha | Hunan | Recruiting |
| Hengyang Central Hospital | Hengyang | Hunan | Recruiting |
| Affiliated Nanhua Hospital, University of South China | Hengyang | Hunan | Recruiting |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | Recruiting |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Recruiting |
| The First Clinical Hospital of Jilin Academy of Chinese Medicine Sciences | Changchun | Jilin | Recruiting |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Tenth People's Hospital / Tenth People's Hospital of Tongji University | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai East Hospital, Tongji University | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Pudong New Area Punan Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | Recruiting |
| Minhang Hospital, Fudan University / Central Hospital of Minhang District, Shanghai | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Qingpu District Central Hospital / Qingpu Branch of Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | Recruiting |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | Recruiting |
| Jiaxing First Hospital | Jiaxing | Zhejiang | Recruiting |
| Ningbo No. 2 Hospital | Ningbo | Zhejiang | Recruiting |
| Ningbo Medical Center Lihuili Hospital | Ningbo | Zhejiang | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07307235 on ClinicalTrials.gov ↗ ← All trials in China