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Clinical Trials in China / NCT07307235
Recruiting Phase 4

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

NCT07307235 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Phase 4
Started
2025-12-13
Last updated
2026-07-07

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

iGlarLixi (insulin glargine/lixisenatide)standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Participant must be at least 18 of age inclusive, at the time of signing the informed consent. 2. Type 2 diabetes mellitus diagnosis. 3. Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs. 4. HbA1c 7.5-11% 5. Further intensification with an additional antidiabetic injectable medication is indicated to achieve glycaemic target at the discretion of the study physician according to approval labelling. Participants who have signed informed consent form (ICF). Exclusion Criteria: 1. Diagnosed with T1DM 2. BMI \<20 kg/m2 or BMI ≥40 kg/m2 3. Treatment with more than 3 oral antidiabetic medications, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of insulin is allowed, as is prior insulin treatment for gestational diabetes. 4. Contraindications to iGlarLixi according to the China NMPA approved label. 5. Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study. 6. Participants who involved in other clinical trial within 3 months prior to the time of screening visit. 7. Participant who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 8. Pregnant or breast-feeding woman. 9. Woman of childbearing potential not protected by highly effective contraceptive method of birth control and/or who is unwilling or unable to be tested for pregnancy. 10. Conditions/situations such as: Participant with short life expectancy. Participant with conditions/concomitant diseases making him/her not evaluable for the primary efficacy endpoint (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to screening). Participant with conditions/concomitant diseases precluding his/her safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period). Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
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

More Shanghai Zhongshan Hospital trials in China

Other trials for the same condition

Official registry record

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