DelfaGLP-1 Atlas

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Lixilan-L-CN

CompletedPhase 3

Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled on Basal Insulin With or Without Oral Antidiabetic Drug(s)

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

45

Recruiting sites

—

Enrollment

426

actual

Study population

Type 2 diabetes

Key I/E criterion

—

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 IDNCT03798080
Org study IDEFC14944
Secondary IDU1111-1190-7781UTN

Timeline

Milestones

Study first posted2019-01-09actual
Study start2019-02-19actual
Primary completion2020-12-01actual
Study completion2020-12-01actual
Last update posted2022-07-19actual

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

•Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and treated with basal insulin for at least 6 months before screening visit (V1).
•Patients who have been treated with a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before screening visit (V1).
•Stable total daily basal insulin dose (±20 %) in the range of 10 and 25 U/day for at least 2 months before screening visit (V1). Total daily dose should be within the range of 10-25 U, both inclusive, on the day of screening, but individual fluctuations of ±20% within 2 months prior to screening are acceptable.
•For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months prior to screening. The OAD(s) can be 1 to 2 out of:
•Metformin (≥1500 mg/day or maximal tolerated dose).
•Sulfonylurea (SU)/glinide.
•Alpha-glucosidase inhibitor (alpha-GI).
•Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
•Dipeptidyl-peptidase-4 (DPP-4) inhibitor.
•Fasting plasma glucose (FPG) ≤160 mg/dL (8.9 mmol/L) at screening visit (V1) (can be repeated once to confirm).
•Signed written informed consent.

Exclusion criteria

•Age <18 years at screening visit (V1).
•Screening glycated hemoglobin A1c(HbA1c) <7.0% or >10.5%.
•History of hypoglycemia unawareness.
•History of metabolic acidosis, including diabetic ketoacidosis within one 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.
•Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin, within one year prior to screening (Note: Short term treatment [≤10 days] due to intercurrent illness is allowed).
•History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reason or lack of efficacy.
•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.
•Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening.
•Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization.
•Planned coronary, carotid, or peripheral revascularization procedures to be performed during the study period.
•Known history of drug or alcohol abuse within 6 months prior to screening.
•Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.
•Laboratory findings at 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/mm3 and/or platelets <100 000/mm3.
•Positive test for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody (HCAb).
•Positive urine pregnancy test in female of childbearing potential.
•For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying.
•History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
•Mean fasting self-monitored plasma glucose (SMPG) is >160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization.

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

Endpoints (13)

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
9
Safety / tolerability / PK
3
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:From Baseline to Week 30

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

9 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:From Baseline to Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Patients with HbA1c <7.0%

Time frame:At Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Patients with HbA1c ≤ 6.5%

Time frame:At Week 30

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in postprandial plasma glucose (PPG)

Time frame:From Baseline to Week 30

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in self-monitored plasma glucose (SMPG) profile

Time frame:From Baseline to Week 30

change from baseline, improvement

Secondary/protocol endpoint

Patients with HbA1c <7.0% with no body weight gain

Time frame:At Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Secondary/protocol endpoint

Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia

Time frame:At Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Secondary/protocol endpoint

Patients requiring rescue therapy

Time frame:From Baseline to Week 30

threshold achievement, event

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From Baseline to Week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Confirmed hypoglycemia

Time frame:From Baseline to Week 30

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:From Baseline to Week 30

Treatment-emergent AEs (any)

event count, event

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

Secondary/protocol endpoint

Immunogenicity (antibody variables)

Time frame:From Baseline to Week 30

Immunogenicity (ADA)

descriptive

Publications (3)

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.