Trial · Interventional
RecruitingPhase 4Registry dataEfficacy 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
- 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
NCT0730723513 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.
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)
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
Total insulin dose in each group at Week 24
Time frame · 24 weeks
Change in fasting C-peptide from baseline to Week 24
Time frame · 24 weeks
Percentage of participants requiring rescue therapy during the 24-week treatment period
Time frame · 24 weeks
Time to first study drug discontinuation during 24 weeks (day)
Time frame · 24 weeks
Time to first treatment intensification (add-on) or change (switch) after randomization during 24 weeks (day)
Time frame · 24 weeks
Study drug medication adherence of the study, as measured by medication possession ratio (MPR) (%)
Time frame · 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.
Time frame · 24 weeks
Registry description
TRIM scores range from 0 to 100 with a higher score indicating a better health state.
All cause healthcare resource utilization (HCRU) from baseline to EOT(end of treatment
Time frame · 24 weeks
Incidence and event rate of hypoglycemia
Time frame · 24 weeks
Registry description
any hypoglycemia, ADA grades 1-2-3
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
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