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Trial · Interventional

RecruitingPhase 4Registry data

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

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
1,316 participants (estimated)
Sponsor
Shanghai Zhongshan Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
13 Dec 2025
Primary completion
30 Jun 2027 (estimated)
Completion
30 Dec 2027 (estimated)
First posted
29 Dec 2025
Last update posted
7 Jul 2026
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 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

    NCT07307235

    13 Dec 2025 to est. 30 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • iGlarLixi (insulin glargine/lixisenatide)Drug
  • standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)Drug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. hemoglobin A1c (HbA1c) change

    Time frame · from baseline to week 24

    Registry description

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

Secondary outcomes(20)
  1. Proportion of subjects achieving HbA1c < 7% at week 24

    Time frame · 24 weeks

  2. 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

  3. Change in weight from baseline to week 24

    Time frame · 24 weeks

  4. Change in Fasting plasma glucose from baseline to Week 24.

    Time frame · 24 weeks

  5. 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

  6. 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

  7. 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

  8. 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

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

    Time frame · 24 weeks

  10. Change in waist from baseline to Week 24

    Time frame · 24 weeks

  11. Total insulin dose in each group at Week 24

    Time frame · 24 weeks

  12. Change in fasting C-peptide from baseline to Week 24

    Time frame · 24 weeks

  13. Percentage of participants requiring rescue therapy during the 24-week treatment period

    Time frame · 24 weeks

  14. Time to first study drug discontinuation during 24 weeks (day)

    Time frame · 24 weeks

  15. Time to first treatment intensification (add-on) or change (switch) after randomization during 24 weeks (day)

    Time frame · 24 weeks

  16. Study drug medication adherence of the study, as measured by medication possession ratio (MPR) (%)

    Time frame · 24 weeks

  17. 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.

    Time frame · 24 weeks

    Registry description

    TRIM scores range from 0 to 100 with a higher score indicating a better health state.

  18. All cause healthcare resource utilization (HCRU) from baseline to EOT(end of treatment

    Time frame · 24 weeks

  19. Incidence and event rate of hypoglycemia

    Time frame · 24 weeks

    Registry description

    any hypoglycemia, ADA grades 1-2-3

  20. Incidence and event rate of Adverse events (AE)

    Time frame · 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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