DelfaGLP-1 Atlas

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LixilanOne CAN

CompletedPhase 3

Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)

A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (T2DM)

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

32

Recruiting sites

—

Enrollment

265

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 20-40•HbA1c 7.5-10.5%

Primary endpoint

•HbA1c, change

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 IDNCT03767543
Org study IDLPS15544
Secondary IDU1111-1215-0238UTN

Timeline

Milestones

Study first posted2018-12-06actual
Study start2019-03-11actual
Primary completion2020-10-23actual
Study completion2020-10-23actual
Last update posted2022-04-25actual

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

•Adult subject ≥ 18 years
•Patients with type 2 diabetes mellitus (T2DM) based on Diabetes Canada 2018 Clinical Practice Guidelines criteria and diagnosed at least 6 months prior to the screening visit
•Uncontrolled glycemia with an A1c ≥7.5% and ≤10.5%
•Patients treated for at least 6 months on any basal insulin (including but not limited to insulin glargine, Toujeo®, Degludec®, etc.) ± oral anti-diabetic drug (OADs)
•The total basal insulin dose must be ≤ 40 units/day
•The OADs allowed at inclusion are metformin, insulin secretagogues, dipeptidyl-peptidase-4 inhibitors (DPP4) inhibitors and SGLT2 inhibitors; with no change in OAD dose for at least 2 months prior to randomization
•Body mass index (BMI) between 20 kg/m2 and 40 kg/m2 inclusively

Exclusion criteria

•History of severe hypoglycemia or hypoglycemia unawareness
•History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening visit
•Current or previous (known intolerance to GLP-1s) treatment with glucagon like peptide-1 (GLP-1) receptor agonist
•Current use of rapid-acting insulin or premix insulins or use of these insulins within 3 months prior to the screening visit
•Use of systemic glucocorticoids (excluding topical and inhaled forms) for a total duration of 1 week or more within 3 months prior to the screening visit
•Use of weight loss drugs within 3 months prior to the screening visit
•Patients with conditions/concomitant diseases that will affect safe participation in this study (e.g. active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require treatment within the study period, etc.)
•Women of childbearing potential (WOCBP) not protected by an effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
•Positive serum pregnancy test in WOCBP, pregnancy or lactation
•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) or uncontrolled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening visit
•History of pancreatitis (unless pancreatitis was related to gallstones and treated with cholecystectomy), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, or stomach/gastric surgery
•Personal or immediate family history of medullary thyroid cancer or genetic conditions that predispose the patient to medullary thyroid cancer (e.g. multiple endocrine neoplasia syndromes)

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

Endpoints (16)

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
11
Safety / tolerability / PK
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight from baseline to Week 26

Time frame:Baseline to Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

11 endpoints
Primary/protocol endpoint

Change in glycated hemoglobin (HbA1c)%

Time frame:Baseline to Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of patients achieving HbA1c ≤7% at Week 26

Time frame:At Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG) from baseline to Week 12

Time frame:Baseline to Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in FPG from baseline to Week 26

Time frame:Baseline to Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12

Time frame:Baseline to Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in fasting SMPG from baseline to Week 26

Time frame:Baseline to Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in 7-point SMPG profile from baseline to Week 12

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in 7-point SMPG profile from baseline to Week 26

Time frame:Baseline to Week 26

change from baseline, improvement

Secondary/protocol endpoint

Percentage of patients achieving A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L) at Week 26

Time frame:Baseline to Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Secondary/protocol endpoint

Insulin glargine dose

Time frame:At Week 26

descriptive

Secondary/protocol endpoint/low confidence

Percentage of patients requiring rescue therapy

Time frame:Baseline to Week 26

threshold achievement, improvement

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Percentage of patients experiencing at least 1 hypoglycemia episode (≤3.9 mmol/L) over 26 weeks

Time frame:Baseline to Week 26

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Percentage of patients experiencing at least 1 hypoglycemia episode (<3.0 mmol/L) over 26 weeks

Time frame:Baseline to Week 26

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Annualized rate of hypoglycemia (≤3.9 mmol/L) over 26 weeks

Time frame:Baseline to Week 26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Annualized rate of hypoglycemia (<3.0 mmol/L) over 26 weeks

Time frame:Baseline to Week 26

Documented hypoglycemia

event count, event

Publications (2)

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

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.