CompletedPhase 3Results posted

iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

582

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≤40

Primary endpoints

•HbA1c•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05413369

Org study IDLPS17396

Secondary IDU1111-1267-2772ICTRP

Timeline

Milestones

Study first posted2022-06-10actual

Study start2022-07-07actual

Primary completion2023-10-20actual

Study completion2023-10-20actual

Results first posted2024-10-30actual

Last update posted2025-09-24actual

Assets

Investigational agents

Lixisenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participant had at least 18 of age inclusive, at the time of signing the informed consent.

•Participants who were diagnosed with T2DM for at least 1 year before the screening visit

•Participants who were treated for at least 3 months prior to the screening visit with a stable dose of metformin (at least 1000 mg/day or the maximum tolerated dose) alone or in combination with a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl-peptidase-4 (DPP-4) inhibitor or a sodium-glucose co-transporter 2 (SGLT-2) inhibitor

•HbA1c at screening visit:

-between 7.5% and 11%, both inclusive, for participants previously treated with metformin alone or + SGLT-2 inhibitor, or

-between 7.0% and 10%, both inclusive, for participants previously treated with metformin + a second oral antidiabetic treatment other than SGLT-2 inhibitor.

•Participants who were overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

•Body mass index (BMI) <40 kg/m² at screening

•Male or female, including females of childbearing potential who agreed to use contraception during the study duration

•Participants were capable of giving signed informed consent as described in Appendix 1 of the protocol which included compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria

•Participant who had a severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²

•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 (e.g., participant unable or unwilling to do self-injections or blood glucose monitoring using the Sponsor-provided blood glucometer at home).

•Previous treatment with insulin (except for short-term treatment ≤14 days due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.

•Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening.

•Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.

•Use of weight loss drugs within 3 months prior to screening.

•History of discontinuation of a previous treatment with GLP-1 RAs due to safety/tolerability reasons or lack of efficacy.

•Use of any investigational drug other than specified in this protocol within 1 month or 5 half-lives, whichever is longer, prior to screening.

•Laboratory findings tested at the screening visit:

-Amylase and/or lipase >3 times the upper limit of normal (ULN) laboratory range.

-Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.

-Total bilirubin >1.5 ULN (except in case of Gilbert's syndrome).

-Calcitonin ≥20 pg/mL (5.9 pmol/L).

-Hemoglobin <10.5 g/dL and/or neutrophils <1500/mm^3 and/or platelets <100 000/mm^3.

-Positive urine pregnancy test in female of childbearing potential.

•Contraindication to metformin and/or SGLT-2 inhibitor use, for those who were taking it prior to the study, according to local labeling, warning/precaution of use (when appropriate) as displayed in the respective National regulation

•Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized

•Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures

•Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6)

•Any specific situation during study implementation/course that may raise ethics considerations

•Sensitivity to any of the study interventions (insulin or, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study

•Participants who withdrawn consent at randomization or were lost to follow up at randomization visit.

The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.

Endpoints (38)

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

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Change in Body Weight From Baseline to Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Least-squares mean · kilogram	95% CI
iGlarLixi	-0.30	-
IDegAsp	1.19	-

Ls mean difference-1.4997.5% CI-2.32 - -0.66p<0.001ANCOVA

Statistical analysis for change from baseline in body weight

Secondary/registry result

Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24

Time frame:Week 24

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
iGlarLixi	40.5	-
IDegAsp	21.3	-

Odds ratio (or)2.5995% CI1.79 - 3.76p<0.001Regression, Logistic

Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24

Secondary/registry result

Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24 and no Hypoglycemia During 24-Week Treatment Period

Time frame:Baseline up to Week 24

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
iGlarLixi	26.5	-
IDegAsp	13.4	-

Odds ratio (or)2.3495% CI1.52 - 3.60p<0.001Regression, Logistic

Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24 and no hypoglycemia during treatment

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 24

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

22 endpoints

Primary/registry result

Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Least-squares mean · percentage of HbA1c	95% CI
iGlarLixi	-1.88	-
IDegAsp	-1.68	-

Least squares (ls) mean difference-0.2095% CI-0.33 - -0.07p<0.001ANCOVA

Statistical analysis for change from baseline in HbA1c

Primary/protocol endpoint

Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in HbA1c From Baseline to Week 24: Superiority Analysis

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Least-squares mean · percentage of HbA1c	95% CI
iGlarLixi	-1.88	-
IDegAsp	-1.68	-

Ls mean difference-0.2097.5% CI-0.35 - -0.05p0.003ANCOVA

Statistical analysis for change from baseline in HbA1c

Secondary/registry result

Percentage of Participants Reaching HbA1c <7% at Week 24

Time frame:Week 24

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
iGlarLixi	72.5	-
IDegAsp	59.8	-

Odds ratio (or)1.8997.5% CI1.25 - 2.85p<0.001Regression, Logistic

Statistical analysis for percentage of participants reaching HbA1c value \<7% at Week 24

Secondary/registry result

Change in Fasting Plasma Glucose From Baseline to Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Least-squares mean · mmol/L	95% CI
iGlarLixi	-3.18	-
IDegAsp	-3.45	-

Secondary/registry result

Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Least-squares mean · mmol/L	95% CI
iGlarLixi	-3.36	-
IDegAsp	-2.92	-

Secondary/registry result

Percentage of Participants Reaching HbA1c <7% at Week 24 With no Hypoglycemia During 24-Week Treatment Period

Time frame:Baseline up to Week 24

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
iGlarLixi	43.6	-
IDegAsp	35.7	-

Secondary/registry result

Percentage of Participants Reaching HbA1c <7% at Week 24 With no Clinically Relevant Hypoglycemia During 24-Week Treatment Period

Time frame:Baseline up to Week 24

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
iGlarLixi	66.7	-
IDegAsp	56.0	-

Secondary/registry result

Total Daily Insulin Dose at Week 24

Time frame:Week 24

descriptive

Posted result

Group	Least-squares mean · units	95% CI
iGlarLixi	27.68	-
IDegAsp	33.78	-

Secondary/registry result

Percentage of Participants Who Required Rescue Therapy During the 24-Week Treatment Period

Time frame:Baseline up to Week 24

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
iGlarLixi	5.2	-
IDegAsp	6.9	-

Secondary/registry result

Change in Fasting C-Peptide From Baseline to Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Least-squares mean · nanomoles/liter (nmol/L)	95% CI
iGlarLixi	-0.23	-
IDegAsp	-0.33	-

Secondary/protocol endpoint

Change in HbA1c From Baseline to Week 24: Superiority Analysis

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7% at Week 24

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24 and no Hypoglycemia During 24-Week Treatment Period

Time frame:Baseline up to Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline to Week 24

Time frame:Baseline, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7% at Week 24 With no Hypoglycemia During 24-Week Treatment Period

Time frame:Baseline up to Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7% at Week 24 With no Clinically Relevant Hypoglycemia During 24-Week Treatment Period

Time frame:Baseline up to Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Total Daily Insulin Dose at Week 24

Time frame:Week 24

descriptive, improvement

Secondary/protocol endpoint

Percentage of Participants Who Required Rescue Therapy During the 24-Week Treatment Period

Time frame:Baseline up to Week 24

threshold achievement, event

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting C-Peptide From Baseline to Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Safety / tolerability / PK

12 endpoints

Secondary/registry result

Number of Participants With Any Hypoglycemia Event During On-Treatment Period

Time frame:From first dose of study drug up to 1 day after the last administration of study drug (maximum treatment exposure: 192 days)

event count, event

Posted result

Group	Participants	95% CI
iGlarLixi	102	-
IDegAsp	118	-

Secondary/registry result

Hypoglycemic Event Rate During the On-Treatment Period

Time frame:From first dose of study drug up to 1 day after the last administration of study drug (maximum treatment exposure: 192 days)

descriptive

Posted result

Group	Number · event rate per participant-year	95% CI
iGlarLixi	1.90	-
IDegAsp	2.72	-

Secondary/registry result

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Adverse Events Of Special Interest (AESIs) and TEAEs Leading to Treatment Discontinuation

Time frame:From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days)

event count, event

Posted result

Group	Participants	95% CI
iGlarLixiAny TEAE	220	-
Any TESAE	15	-
Any AESI	6	-
Any TEAE leading to treatment discontinuation	7	-
IDegAspAny TEAE	192	-
Any TESAE	12	-
Any AESI	2	-
Any TEAE leading to treatment discontinuation	1	-

Secondary/registry result

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs

Time frame:From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days)

event count, event

Posted result

Group	Participants	95% CI
iGlarLixiSBP: <=95 mmHg and decrease from baseline >=20 mmHg	1	-
SBP: >=160 mmHg and increase from baseline >=20 mmHg	4	-
DBP :<=45 mmHg and decrease from baseline >=10 mmHg	0	-
DBP: >=110 mmHg and increase from baseline >=10 mmHg	0	-
HR: <=50 beats/min and decrease from baseline >=20 beats/min	0	-
HR: >=120 beats/min and increase from baseline >=20 beats/min	0	-
Weight: >=5% decrease from baseline	41	-
Weight: >=5% increase from baseline	29	-
IDegAspSBP: <=95 mmHg and decrease from baseline >=20 mmHg	1	-
SBP: >=160 mmHg and increase from baseline >=20 mmHg	7	-
DBP :<=45 mmHg and decrease from baseline >=10 mmHg	0	-
DBP: >=110 mmHg and increase from baseline >=10 mmHg	0	-
HR: <=50 beats/min and decrease from baseline >=20 beats/min	0	-
HR: >=120 beats/min and increase from baseline >=20 beats/min	0	-
Weight: >=5% decrease from baseline	19	-
Weight: >=5% increase from baseline	73	-

Secondary/registry result

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology

Time frame:From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days)

event count, event

Posted result

Group	Participants	95% CI
iGlarLixiHb: <=115 g/L (M); <=95 g/L (F)	4	-
Hb: >=185 g/L (M); >=165 g/L (F)	1	-
Hb: Decrease from Baseline >=20 g/L	25	-
Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F)	2	-
Hematocrit: >=0.55 v/v (M) or >=0.5 v/v (F)	37	-
RBC: >=6 Tera/L	5	-
Platelets: <100 Giga/L	3	-
Platelets: >=700 Giga/L	0	-
WBC: <3.0 Giga/L (NB); < 2.0 Giga/L (B)	2	-
WBC: >=16.0 Giga/L	1	-
Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B)	5	-
Lymphocytes: > 4.0 Giga/L	4	-
Monocytes: >0.7 Giga/L	35	-
Basophils: >0.1 Giga/L	2	-
Eosinophils: >0.5 Giga/L or >ULN	2	-
IDegAspHb: <=115 g/L (M); <=95 g/L (F)	1	-
Hb: >=185 g/L (M); >=165 g/L (F)	4	-
Hb: Decrease from Baseline >=20 g/L	19	-
Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F)	6	-
Hematocrit: >=0.55 v/v (M) or >=0.5 v/v (F)	30	-
RBC: >=6 Tera/L	6	-
Platelets: <100 Giga/L	7	-
Platelets: >=700 Giga/L	0	-
WBC: <3.0 Giga/L (NB); < 2.0 Giga/L (B)	3	-
WBC: >=16.0 Giga/L	0	-
Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B)	7	-
Lymphocytes: > 4.0 Giga/L	6	-
Monocytes: >0.7 Giga/L	29	-
Basophils: >0.1 Giga/L	5	-
Eosinophils: >0.5 Giga/L or >ULN	2	-

Secondary/registry result

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry

Time frame:From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days)

event count, event

Posted result

Group	Participants	95% CI
iGlarLixiLipase: >=3 ULN	6	-
Amylase: >=3 ULN	0	-
Sodium: <=129 mmol/L	0	-
Sodium: >=160 mmol/L	0	-
Potassium: <3 mmol/L	0	-
Potassium: >=5.5 mmol/L	1	-
Creatinine: >=150 umol/L	0	-
Creatinine: >=30% change from baseline	36	-
Creatinine: >=100% change from baseline	0	-
GFR: Mild decrease in GFR	80	-
GFR: Moderate decrease in GFR	11	-
GFR: Severe decrease in GFR	0	-
GFR: End stage renal disease	0	-
CG: Mild decrease in GFR	80	-
CG: Moderate decrease in GFR	12	-
CG: Severe decrease in GFR	0	-
CG: End stage renal disease	0	-
BUN: >=17 mmol/L	0	-
Uric Acid: <120 umol/L	0	-
Uric Acid: >408 umol/L	104	-
ALT: >3 ULN	4	-
ALT: >5 ULN	1	-
ALT: >10 ULN	1	-
ALT: >20 ULN	0	-
AST: >3 ULN	0	-
AST: >5 ULN	1	-
AST: >10 ULN	0	-
AST: >20 ULN	0	-
Alkaline Phosphatase: >1.5 ULN	2	-
TBILI: >1.5 ULN	3	-
TBILI: >2 ULN	1	-
ALT>3ULN and TBILI >2 ULN	0	-
Conjugated and TBILI: >35% TBILI and TBILI >1.5 ULN	2	-
IDegAspLipase: >=3 ULN	9	-
Amylase: >=3 ULN	0	-
Sodium: <=129 mmol/L	0	-
Sodium: >=160 mmol/L	0	-
Potassium: <3 mmol/L	0	-
Potassium: >=5.5 mmol/L	3	-
Creatinine: >=150 umol/L	1	-
Creatinine: >=30% change from baseline	29	-
Creatinine: >=100% change from baseline	1	-
GFR: Mild decrease in GFR	79	-
GFR: Moderate decrease in GFR	11	-
GFR: Severe decrease in GFR	1	-
GFR: End stage renal disease	0	-
CG: Mild decrease in GFR	85	-
CG: Moderate decrease in GFR	16	-
CG: Severe decrease in GFR	0	-
CG: End stage renal disease	0	-
BUN: >=17 mmol/L	0	-
Uric Acid: <120 umol/L	0	-
Uric Acid: >408 umol/L	108	-
ALT: >3 ULN	2	-
ALT: >5 ULN	0	-
ALT: >10 ULN	0	-
ALT: >20 ULN	0	-
AST: >3 ULN	0	-
AST: >5 ULN	0	-
AST: >10 ULN	0	-
AST: >20 ULN	0	-
Alkaline Phosphatase: >1.5 ULN	5	-
TBILI: >1.5 ULN	1	-
TBILI: >2 ULN	0	-
ALT>3ULN and TBILI >2 ULN	0	-
Conjugated and TBILI: >35% TBILI and TBILI >1.5 ULN	0	-

Secondary/protocol endpoint

Number of Participants With Any Hypoglycemia Event During On-Treatment Period

Time frame:From first dose of study drug up to 1 day after the last administration of study drug (maximum treatment exposure: 192 days)

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Hypoglycemic Event Rate During the On-Treatment Period

Time frame:From first dose of study drug up to 1 day after the last administration of study drug (maximum treatment exposure: 192 days)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Time frame:From signature of the informed consent form up to the final visit regardless of seriousness or relationship to study drug (maximum treatment exposure: 192 days)

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Vital Signs

Time frame:From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days)

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change, Body weight, absolute change (kg)

Secondary/protocol endpoint

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematology

Time frame:From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days)

threshold achievement, event

componentshemoglobin abnormal, hematocrit abnormal, rbc abnormal, platelets abnormal, wbc abnormal, neutrophils abnormal, lymphocytes abnormal, monocytes abnormal, basophils abnormal

Secondary/protocol endpoint

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Clinical Chemistry

Time frame:From first dose of study drug up to 3 days after last administration of study drug (maximum treatment exposure: 192 days)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 6, 2026 snapshot.