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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
Lead sponsor
Asset
Lixisenatide
Subcutaneous · GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
1,316
estimated
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 7.5-11%
Primary endpoint
•HbA1c, change
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (25)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChange in weight from baseline to week 24
Time frame:24 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Change in waist from baseline to Week 24
Time frame:24 weeks
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
13 endpointshemoglobin A1c (HbA1c) change
Time frame:from baseline to week 24
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Proportion of subjects achieving HbA1c < 7% at week 24
Time frame:24 weeks
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
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
HbA1c <7.0% achievement
threshold achievement, improvement
componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia
LOINC 4548-4
Change in Fasting plasma glucose from baseline to Week 24.
Time frame:24 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
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
change from baseline, improvement
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
HbA1c <7.0% achievement
threshold achievement, improvement
componentsHbA1c <7.0% achievement, Documented hypoglycemia, Severe hypoglycemia
LOINC 4548-4
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
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
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 from baseline, improvement
Change in proportion of patients achieving CGM metrics targets (TIR / TAR / TBR / TITR / CV) from baseline to Week 24
Time frame:24 weeks
threshold achievement, improvement
Total insulin dose in each group at Week 24
Time frame:24 weeks
descriptive
Change in fasting C-peptide from baseline to Week 24
Time frame:24 weeks
C-peptide AUC
change from baseline, improvement
Percentage of participants requiring rescue therapy during the 24-week treatment period
Time frame:24 weeks
threshold achievement, event
Time to first treatment intensification (add-on) or change (switch) after randomization during 24 weeks (day)
Time frame:24 weeks
time to event, event
Cardiometabolic biomarkers
1 endpointChange in CRP from baseline to week 24.
Time frame:from baseline to week 24
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Patient-reported / QoL
1 endpointChange 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
change from baseline, improvement
Safety / tolerability / PK
6 endpointsTime to first study drug discontinuation during 24 weeks (day)
Time frame:24 weeks
Discontinuation due to AE
time to event, event
Incidence and event rate of hypoglycemia
Time frame:24 weeks
Documented hypoglycemia
event count, event
Incidence and event rate of Adverse events (AE)
Time frame:24 weeks
Treatment-emergent AEs (any)
event count, event
Incidence and event rate of serious adverse events (SAE)
Time frame:24 weeks
Serious AEs (any)
event count, event
Incidence and event rate of adverse events of special interest (AESI)
Time frame:24 weeks
event count, event
componentspregnancy event, overdose event, alt elevation gt 3x uln
Incidence and event rate of AEs leading to treatment discontinuation, vital signs, and safety laboratory test values.
Time frame:24 weeks
Discontinuation due to AE
descriptive, event
componentsDiscontinuation due to AE, Treatment-emergent AEs (any)
Other clinical outcomes
1 endpointAll cause healthcare resource utilization (HCRU) from baseline to EOT（end of treatment
Time frame:24 weeks
descriptive
Other (unclassified)
1 endpointStudy drug medication adherence of the study, as measured by medication possession ratio (MPR) (%)
Time frame:24 weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.