Current partner codePEPTIDESDE
NCT07307235·Phase 4·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 4

Enrollment

1,316

Locations

24

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

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.

Timeline

From registration to results.

  1. First posted

    Dec 29, 2025

  2. Study start

    Dec 13, 2025

  3. Primary completion

    Jun 30, 2027

  4. Study completion

    Dec 30, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 7, 2026

Outcomes

What the study measures.

Primary outcomes

hemoglobin A1c (HbA1c) change

Time frame · from baseline to week 24

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

Secondary outcomes

Proportion of subjects achieving HbA1c < 7% at week 24

Time frame · 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

Time frame · 24 weeks

Change in weight from baseline to week 24

Time frame · 24 weeks

Change in Fasting plasma glucose from baseline to Week 24.

Time frame · 24 weeks

Change in 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 24 (each time point and average daily value).

Time frame · 24 weeks

Proportion of participants reaching HbA1c target <7% with no hypoglycemia (defined as ADA level 1, 2 or 3) at Week 24.

Time frame · 24 weeks

Proportion of participants reaching HbA1c target <7% with no clinically relevant hypoglycemia (defined as ADA level 2 or 3) at Week 24

Time frame · 24 weeks

Change in CGM metrics(TIR / TAR / TBR /mean daily glucose / TITR / CV / GMI / SD of mean glucose) from baseline to Week 24

Time frame · 24 weeks

Change in proportion of patients achieving CGM metrics targets (TIR / TAR / TBR / TITR / CV) from baseline to Week 24

Time frame · 24 weeks

Change in waist from baseline to Week 24

Time frame · 24 weeks

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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.

Study locations

24 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

The First Affiliated Hospital of USTC / Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The First People's Hospital of Huizhou

Huizhou, Guangdong, China

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, China

Xinxiang Central Hospital

Xinxiang, Henan, China

Wuhan Fourth Hospital / Wuhan Puai Hospital

Wuhan, Hubei, China

Hunan Provincial People's Hospital / The First Affiliated Hospital of Hunan Normal University

Changsha, Hunan, China

Hengyang Central Hospital

Hengyang, Hunan, China

Affiliated Nanhua Hospital, University of South China

Hengyang, Hunan, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Clinical Hospital of Jilin Academy of Chinese Medicine Sciences

Changchun, Jilin, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital / Tenth People's Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Shanghai East Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Shanghai Pudong New Area Punan Hospital

Shanghai, Shanghai Municipality, China

Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Minhang Hospital, Fudan University / Central Hospital of Minhang District, Shanghai

Shanghai, Shanghai Municipality, China

Shanghai Qingpu District Central Hospital / Qingpu Branch of Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Jiaxing First Hospital

Jiaxing, Zhejiang, China

Ningbo No. 2 Hospital

Ningbo, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

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