Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population W… (NCT07307235) | Clinical Trial Compass
RecruitingPhase 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
China1,316 participantsStarted 2025-12-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must be at least 18 of age inclusive, at the time of signing the informed consent.
. Type 2 diabetes mellitus diagnosis.
. Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs.
. HbA1c 7.5-11%
. 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.
Exclusion criteria
. Diagnosed with T1DM
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is comparing iGlarLixi — a combination of basal insulin and a GLP-1 receptor agonist — to whatever my doctor considers 'standard of care,' can you explain what that standard of care option would be for me, and how iGlarLixi differs from it in terms of how I'd take it and what side effects to expect?
2This is a Phase 4 trial, which means iGlarLixi is already approved — does that mean there's more known about its safety compared to earlier-phase studies, and how does that affect your confidence in recommending it for my situation?
3The trial is measuring HbA1c reduction as its main goal — given where my HbA1c currently stands, do you think I'm a good candidate for a study like this, or would a different treatment approach be more appropriate for me first?
4Since this is described as a 'real-world' study conducted in China, and I may be in a different setting, does my eligibility or the relevance of the results change based on where I'm being treated or my background?
5If I join this trial and my blood sugar control doesn't improve enough, would I be able to switch to a different treatment mid-study, or would I need to complete the trial before trying something else?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Contraindications to iGlarLixi according to the China NMPA approved label.
. 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.
. Participants who involved in other clinical trial within 3 months prior to the time of screening visit.
. Participant who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2