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

NCT ID: NCT07307235

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2027-12-30

Brief 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

Keywords

diabetes; iGlarLixi; RCT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iGlarLixi group

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.

Group Type: EXPERIMENTAL

iGlarLixi (insulin glargine/lixisenatide)

Intervention Type: DRUG

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 (SOC) group.

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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 (Met, SGLT2i, alpha-GI, glinide or SU).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi (China) Investment Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiaoying li, Professor

Role: CONTACT

Phone: +862164041990

Email: li.xiaoying@zs-hospital.sh.cn

Other Identifiers

20250424044409703

Identifier Type: -

Identifier Source: org_study_id