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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: iGlarLixi (insulin glargine/lixisenatide); Drug: standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)

• Study Type: Interventional
• Enrollment (Estimated): 1316
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaoying li, Professor; Phone Number: +862164041990; Email: li.xiaoying@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin A1c (HbA1c) change	The primary endpoint is the change in HbA1c from baseline to week 24 (percentage [%]).	from baseline to week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects achieving HbA1c < 7% at week 24		24 weeks
Proportion of subjects achieving HbA1c < 7%, with no weight gain and no hypoglycemia (defined as ADA grades 1, 2, or 3) at week 24		24 weeks
Change in weight from baseline to week 24		24 weeks
Change in Fasting plasma glucose from baseline to Week 24.		24 weeks
Change in 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 24 (each time point and average daily value).		24 weeks
Proportion of participants reaching HbA1c target <7% with no hypoglycemia (defined as ADA level 1, 2 or 3) at Week 24.		24 weeks
Proportion of participants reaching HbA1c target <7% with no clinically relevant hypoglycemia (defined as ADA level 2 or 3) at Week 24		24 weeks
Change in CGM metrics(TIR / TAR / TBR /mean daily glucose / TITR / CV / GMI / SD of mean glucose) from baseline to Week 24		24 weeks
Change in proportion of patients achieving CGM metrics targets (TIR / TAR / TBR / TITR / CV) from baseline to Week 24		24 weeks
Change in waist from baseline to Week 24		24 weeks
Total insulin dose in each group at Week 24		24 weeks
Change in fasting C-peptide from baseline to Week 24		24 weeks
Percentage of participants requiring rescue therapy during the 24-week treatment period		24 weeks
Time to first study drug discontinuation during 24 weeks (day)		24 weeks
Time to first treatment intensification (add-on) or change (switch) after randomization during 24 weeks (day)		24 weeks
Study drug medication adherence of the study, as measured by medication possession ratio (MPR) (%)		24 weeks
Change from baseline to Week 24 in diabetes medication treatment satisfaction scores (total score and by sub scales), using the treatment related impact measure diabetes (TRIM-D) questionnaire.	TRIM scores range from 0 to 100 with a higher score indicating a better health state.	24 weeks
All cause healthcare resource utilization (HCRU) from baseline to EOT（end of treatment		24 weeks
Incidence and event rate of hypoglycemia	any hypoglycemia, ADA grades 1-2-3	24 weeks
Incidence and event rate of Adverse events (AE)		24 weeks
Incidence and event rate of serious adverse events (SAE)	An SAE is defined as any adverse event occurring at any dose that meets one or more of the following criteria: Results in death; Is life-threatening; Requires hospitalization or prolongs existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Other important medical events	24 weeks
Incidence and event rate of adverse events of special interest (AESI)	The following events are designated as AESIs: Pregnancy in female subjects or pregnancy in female partners of male subjects exposed to IMP/NIMP; Symptomatic overdose of IMP/NIMP (serious or non-serious); Alanine aminotransferase (ALT) elevation >3×ULN	24 weeks
Incidence and event rate of AEs leading to treatment discontinuation, vital signs, and safety laboratory test values.		24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CRP from baseline to week 24.	Change in CRP from baseline to week 24.	from baseline to week 24

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Sanofi (China) Investment Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; RCT; iGlarLixi
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Health Services Administration; Health Care Quality, Access, and Evaluation; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Quality of Health Care; Quality Indicators, Health Care; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Insulin Glargine; Standard of Care; lixisenatide
• Other Study ID Numbers: 20250424044409703

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No