DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06671587

China Soli-CGM

RecruitingPhase 4

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

678

estimated

Study population

Type 2 diabetes

Key I/E criterion

•BMI 20-40

Primary endpoint

•CGM time-in-range

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06671587
Org study IDLPS18034
Secondary IDU1111-1306-6660ICTRP

Timeline

Milestones

Study first posted2024-11-04actual
Study start2024-12-10actual
Last update posted2026-03-17actual
Primary completion2026-09-18estimated
Study completion2026-09-18estimated

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Participants who are diagnosed as T2D of at least 1 year before screening visit
•Participants who are treated at least 3 months prior to screening visit with a stable dose of metformin alone or in combination with a second OAD
•Inadequate control
•Body mass index (BMI) within the range 20-40 kg/m2 (inclusive)
•Is willing and able to wear the CGM device continuously
•Is willing to discontinue daily (oral) SU, glinide, alpha-GI, and DPP-4i
•Not using another CGM device during the study

Exclusion criteria

•Participants with severe renal dysfunction
•Participants with short life expectancy
•Participants with conditions/concomitant diseases making them non evaluable for the efficacy endpoints
•Participants with conditions/concomitant diseases precluding their safe participation in this study
•An episode of severe hypoglycemia requiring the assistance of a third party within 3 months before screening visit
•History of clinically significant pancreatitis or severe gastrointestinal disorders
•Participants who have any history of severe multiple allergies or an allergy resulting in anaphylaxis, or contraindication/hypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
•Previous treatment with insulin
•Use of any glucose-lowering agents other than metformin alone or in combination with a second OAD (can be a SU, a glinide, an alpha-GI, a DPP-4i, or a SGLT-2i)
•Use of systemic glucocorticoids
•Use of weight loss drugs
•History of discontinuation of a previous treatment with GLP-1 RA for safety/tolerability reasons or lack of efficacy
•Laboratory findings at the screening visit
•Participants have any current or previous skin conditions
•Participants unwilling or unable to do blood glucose monitoring using the Sponsor-provided blood glucometer at home

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Endpoints (31)

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
22
Safety / tolerability / PK
4
Other (unclassified)
3
Weight & body composition
1
Patient-reported / QoL
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change (kg) in body weight

Time frame:from baseline to Week 20

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

22 endpoints
Primary/protocol endpoint

Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)]

Time frame:from baseline to Week 20

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

2a Proportion (%) of participants achieving TIR target as >70%

Time frame:Week 20

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

2b Change (%) in TAR >10.0 mmol/L (>180 mg/dL)

Time frame:from baseline to Week 20

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

2c Change (mg/dL) in mean daily glucose

Time frame:from baseline to Week 20

change from baseline, improvement

Secondary/protocol endpoint

2d Proportion (%) of participants achieving composite target of TIR as >70% [3.9-10.0 mmol/L (70-180 mg/dL)] with TAR as <25% [>10.0 mmol/L (>180 mg/dL)] with TBR as <4% [<3.9 mmol/L (<70 m)/dL)]

Time frame:Week 20

threshold achievement, improvement

componentsCGM time-in-range, CGM time-above-range, CGM time-below-range

Secondary/protocol endpoint

Change (%) in coefficient of variation (CV)

Time frame:from baseline to Week 20

percent change from baseline, improvement

Secondary/protocol endpoint

Change (%) in the percentage of time in tight range (TITR) [3.9-7.8 mmol/L (70-140 mg/dL)]

Time frame:from baseline to Week 20

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion (%) of participants achieving TITR [3.9-7.8 mmol/L (70-140 mg/dL)] >50%

Time frame:Week 20

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Proportion (%) of participants achieving ≥5% TIR improvement

Time frame:from baseline to Week 20

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Proportion (%) of participants achieving ≥10% TIR improvement

Time frame:from baseline to Week 20

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Change (%) in TAR >13.9 mmol/L (>250 mg/dL)

Time frame:from baseline to Week 20

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Change (%) in time below range (TBR)

Time frame:from baseline to Week 20

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Change in mean glucose standard deviation (SD)

Time frame:from baseline to Week 20

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change (%) in glucose management indicator (GMI)

Time frame:from baseline to Week 20

percent change from baseline, improvement

Secondary/protocol endpoint

Change (%) in HbA1c

Time frame:from baseline to Week 12 and Week 20

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion (%) of participants achieving HbA1c <7%

Time frame:Week 12 and Week 20

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia

Time frame:Week 20

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion (%) of participants achieving HbA1c <7% without body weight gain

Time frame:Week 20

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion (%) of participants achieving HbA1c <7% without documented hypoglycemia and without body weight gain

Time frame:Week 20

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change (mmol/L) in fasting plasma glucose (FPG), 2-hour postprandial glucose (PPG)

Time frame:from baseline to Week 12 and Week 20

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change (nmol/L) in fasting C-peptide and post-prandial C-peptide

Time frame:from baseline to Week 12 and Week 20

C-peptide AUC

change from baseline, improvement

componentsC-peptide AUC, Postprandial glucose

Secondary/protocol endpoint

Change (%) in TIR [3.9-10.0 mmol/L (70-180 mg/dL)], TAR [>10.0 mmol/L (>180 mg/dL)] and TBR [3.0 mmol/L (<54 mg/dL)] for specific time blocks (6 am-12 pm, 12 pm-6 pm, 6 pm-12 am, and 12 am-6 am)

Time frame:from baseline to Week 20

CGM time-in-range

percent change from baseline, improvement

componentsCGM time-in-range, CGM time-above-range, CGM time-below-range

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in diabetes medication treatment satisfaction scores (total score and by subscales), using the treatment-related impact measure diabetes (TRIM-D) questionnaire

Time frame:from baseline to Week 20

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

AE, serious adverse event (SAE), and adverse event of special interest (AESI)

Time frame:from screening to week 21

Serious AEs (any)

descriptive, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Overall hypoglycemia events and rates

Time frame:from screening to week 21

event count, event

Secondary/protocol endpoint

Nocturnal (00:00 h-05:59 h) hypoglycemia events and rates

Time frame:from baseline to Week 20

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Confirmed hypoglycemia (ADA Level 1, 2 and 3)

Time frame:from baseline to Week 20

Documented hypoglycemia

event count, event

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Proportion (%) of participants achieving CV <36%

Time frame:Week 20

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Proportion (%) of participants achieving CV <32%

Time frame:Week 20

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Change (U and U/Kg) in insulin dose

Time frame:from baseline to Week 20

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.