Soli-CGM

CompletedPhase 4Results posted

Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus

A 16-week, Multicenter, Prospective, Open-label, Single-arm, Phase 4 Study to Evaluate the Effect of Soliqua™ 100/33 on the Percentage of Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Insulin-naïve Patients With Very Uncontrolled Type 2 Diabetes Mellitus

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

124

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 9-13%

Primary endpoints

•The Percentage of Time in Range [70 to 180 Milligram•CGM time-in-range

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 IDNCT05114590

Org study IDLPS16990

Secondary IDU1111-1261-7399ICTRP

Timeline

Milestones

Study first posted2021-11-10actual

Study start2022-01-27actual

Primary completion2023-03-28actual

Study completion2023-04-14actual

Results first posted2024-05-24actual

Last update posted2025-09-09actual

Assets

Investigational agents

Lixisenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with Type 2 Diabetes mellitus (T2DM) for at least 6 months before the baseline period

•HbA1c ≥9-13% during the run-in period

•On at least 2 OADs with or without GLP-1 RA with stable doses (for both) for 3 months prior to the screening period

•Willing and able to wear the CGM device continuously for 14 days to capture CGM measures at baseline until the next site visit and again towards the end of the treatment period

•Willing and able to prick fingers a minimum of 2-4 times per week utilizing sterile lancets provided along with a manual blood glucose meter kit

•Willing to discontinue the daily (oral or injectable) or weekly GLP-1 RA or DPP 4i prior to administration of iGlarLixi (Soliqua 100/33)

•Willing and able to inject iGlarLixi (Soliqua 100/33) and increase dose as needed to achieve SMPG target

•Non-pregnant, non-breastfeeding women utilizing a highly-effective contraceptive method or of non-childbearing potential

Exclusion criteria

•Type1 Diabetes mellitus (T1DM) or any other types of diabetes, except T2DM

•On meglitinides (eg, nateglinide, repaglinide)

•Body mass index (BMI) >40 kg/m² during the screening period

•Any current or previous skin conditions, including (but not limited to) severe psoriasis, burns, eczema, scarring, excessive tattoos, that would inhibit the proper wearing of the CGM device

•History of severe nausea and vomiting leading to subsequent discontinuation of GLP-1 RA

•Known history or presence of clinically significant pancreatitis or gastroparesis

•Participants with an episode of severe hypoglycemia or with hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms [for example, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion] or as the failure to sense a significant fall in blood glucose below normal levels) diagnosed within the 6 months prior to the screening period

•Participants with personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposed to MTC (eg, multiple endocrine neoplasia syndromes)

•Significant current (within past 2 months) and/or expected use of medications known to affect glycemia (eg, ≥5 mg/day prednisone)

•Use of substances known to interfere with CGM readings, such as aspirin-containing products (>650 mg/day of salicylic acid) or supplements containing vitamin C (>1000 mg/day of ascorbic acid) during the 14 days of CGM at either baseline or end of treatment period

•Previous treatment with any insulin (except for short term treatment due to intercurrent illness, including gestational diabetes, at the discretion of the investigator)

•Had used weight loss drugs (including over the counter and herbal medications) within 12 weeks before the screening visit

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

Endpoints (28)

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

Patient-reported / QoL

Other (unclassified)

Glycemic / diabetes

22 endpoints

Primary/registry result

Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Posted result

Group	Mean · percentage of time	95% CI
iGlarLixi	26.22	20.5 - 31.9

Primary/protocol endpoint

Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]

Time frame:Baseline (Days -14 to -1) and Week 16

CGM time-in-range

change from baseline, improvement

Secondary/registry result

Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV)

Time frame:Baseline (Days -14 to -1) and Week 16

percent change from baseline, improvement

Posted result

Group	Mean · percent change	95% CI
iGlarLixi	5.0	3.8 - 6.1

Secondary/registry result

Change From Baseline to Week 16 in Mean Daily Blood Glucose

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Posted result

Group	Mean · mg/dL	95% CI
iGlarLixi	-52.48	-64.6 - -40.3

Secondary/registry result

Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Posted result

Group	Mean · mg/dL	95% CI
iGlarLixi	-73.66	-90.9 - -56.4

Secondary/registry result

Change From Baseline to Week 16 in Time Above Range (>180 mg/dL)

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Posted result

Group	Mean · percentage of time	95% CI
iGlarLixi	-28.67	-34.6 - -22.7

Secondary/registry result

Change From Baseline to Week 16 in Time in Range Per Time Blocks

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Posted result

Group	Mean · percentage of time	95% CI
iGlarLixi12 am to 6 am	27.89	21.3 - 34.5
6 am to 12 pm	33.73	27.0 - 40.5
12 pm to 6 pm	31.05	24.5 - 37.6
6 pm to 12 am	25.87	19.8 - 31.9
6 am to 12 am	30.21	24.1 - 36.3

Secondary/registry result

Percentage of Participants Who Achieved Glucose Management Indicator (GMI) <7% and <9%

Time frame:Week 16

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
iGlarLixiGMI <7%	43.0	33.1 - 53.3
GMI <9%	85.0	76.5 - 91.4

Secondary/registry result

Change From Baseline to Week 16 in the 4-Hour Postprandial Glucose Area Under the Concentration Time Curve From 0 to 4 Hours

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Posted result

Group	Mean · mg/dL*hour	95% CI
iGlarLixi	-325.93	-390.6 - -261.2

Secondary/registry result

Change From Baseline to Week 16 in Time to Reach Maximum Postprandial Glucose Concentration

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Posted result

Group	Mean · hour	95% CI
iGlarLixi	-0.24	-0.5 - 0.0

Secondary/registry result

Percentage of Participants Who Spent <15 Minutes/Day at a Glucose Level <54 mg/dL

Time frame:Week 16

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
iGlarLixi	63.0	52.8 - 72.4

Secondary/registry result

Change From Baseline to Week 16 in Overall Score of Diabetes Medication Treatment Satisfaction Scores Using the Diabetes Medication Satisfaction Tool (DM-SAT) Questionnaire

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Posted result

Group	Mean · units on a scale	95% CI
iGlarLixi	0.18	0.14 - 0.22

Secondary/registry result

Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels

Time frame:From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks)

event count, event

Posted result

Group	Participants	95% CI
iGlarLixiAny Hypoglycemia events	35	-
Hypoglycemia events confirmed by ADA criteria	29	-
ADA Level 1 hypoglycemia	26	-
ADA Level 2 hypoglycemia	11	-
ADA Level 3 hypoglycemia	0	-

Secondary/protocol endpoint

Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV)

Time frame:Baseline (Days -14 to -1) and Week 16

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 16 in Mean Daily Blood Glucose

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal

Time frame:Baseline (Days -14 to -1) and Week 16

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 16 in Time Above Range (>180 mg/dL)

Time frame:Baseline (Days -14 to -1) and Week 16

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Coefficient of Variation <36%

Time frame:Week 16

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline to Week 16 in Time in Range Per Time Blocks

Time frame:Baseline (Days -14 to -1) and Week 16

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Glucose Management Indicator (GMI) <7% and <9%

Time frame:Week 16

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline to Week 16 in the 4-Hour Postprandial Glucose Area Under the Concentration Time Curve From 0 to 4 Hours

Time frame:Baseline (Days -14 to -1) and Week 16

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 16 in Time to Reach Maximum Postprandial Glucose Concentration

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change From Baseline to Week 16 in Overall Score of Diabetes Medication Treatment Satisfaction Scores Using the Diabetes Medication Satisfaction Tool (DM-SAT) Questionnaire

Time frame:Baseline (Days -14 to -1) and Week 16

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events

Time frame:From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks)

event count, event

Posted result

Group	Participants	95% CI
iGlarLixiAny TEAE	47	-
Any treatment-emergent SAE	1	-

Secondary/protocol endpoint

Percentage of Participants Who Spent <15 Minutes/Day at a Glucose Level <54 mg/dL

Time frame:Week 16

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels

Time frame:From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events

Time frame:From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks)

Treatment-emergent AEs (any)

event count, event

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

Other (unclassified)

1 endpoint

Secondary/registry result/low confidence

Percentage of Participants Who Achieved Coefficient of Variation <36%

Time frame:Week 16

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
iGlarLixi	76.0	66.4 - 84.0

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effect of iGlarLixi on continuous glucose monitoring-measured time in range in insulin-naive adults with suboptimally controlled type 2 diabetes.
Diabetes, obesity & metabolism2025 Apr (month)PMID39905643doi:10.1111/dom.16214via pubmed nct search

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.