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 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 20250424044409703
• Study Type: interventional
• Target: 1,316
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• hemoglobin A1c (HbA1c) change

  The primary endpoint is the change in HbA1c from baseline to week 24 (percentage \[%\]).

  from baseline to week 24

Secondary Outcomes (23)

• 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

Other Outcomes (1)

• Change in CRP from baseline to week 24.

  from baseline to week 24

Study Arms (2)

iGlarLixi group

EXPERIMENTAL

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)

Standard of care (SOC) group.

ACTIVE COMPARATOR

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)

Interventions

iGlarLixi (insulin glargine/lixisenatide) 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.

iGlarLixi group

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

Standard of care (SOC) group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (Met, SGLT2i, alpha-GI, glinide or SU).
• 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.
• Participants who have signed informed consent form (ICF).

You may not qualify if:

• Diagnosed with T1DM
• BMI \<20 kg/m2 or BMI ≥40 kg/m2
• 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
• Pregnant or breast-feeding woman.
• 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.
• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Sanofi (China) Investment Co., Ltd: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Insulin Glargine; lixisenatide; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Xiaoying li, Professor

CONTACT

+862164041990; li.xiaoying@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 29, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-06