DelfaGLP-1 Atlas

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Lixilan-O-AP

CompletedPhase 3

Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

A Randomized, 24 Week, Active-controlled, Open-label, 3-arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to Insulin Glargine and Lixisenatide in Type 2 Diabetes Mellitus Patients Insufficiently Controlled With Oral Antidiabetic Drug(s)

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

79

Recruiting sites

—

Enrollment

878

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 IDNCT03798054
Org study IDEFC14943
Secondary IDU1111-1190-7669UTN

Timeline

Milestones

Study first posted2019-01-09actual
Study start2019-02-15actual
Primary completion2021-03-01actual
Study completion2021-03-01actual
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 before the screening visit (V1), treated for at least 3 months prior to the screening visit (V1) with metformin alone or metformin and 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 and who are not adequately controlled with this treatment.
•Signed written informed consent.

Exclusion criteria

•Age < legal age of majority at the screening visit (V1).
•Body mass index (BMI) >40 kg/m² at screening.
•Glycated hemoglobin A1c (HbA1c) at screening visit:
•<7.5% or >11% for patients previously treated with metformin alone;
•<7.0% or >10% for patients previously treated with metformin and a second oral antidiabetic treatment.
•History of hypoglycemia unawareness.
•History of metabolic acidosis, including diabetic ketoacidosis 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.
•Previous treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.
•History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reasons 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 other than specified in this protocol 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 artery 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 (V1):
•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 urine pregnancy test in female of childbearing potential.
•Patient who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
•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).
•Use of SU, glinide, alpha-GI, DPP-4 inhibitor, and SGLT-2 inhibitor after start of run-in (from V2 [Week -4]).
•HbA1c at V4 (Week -1) : <7.0% or >10%.
•Fasting plasma glucose >250 mg/dL (13.9 mmol/L) at V4 (Week-1) (can be repeated once to confirm).
•Metformin maximal tolerated dose <1500 mg/day.
•Amylase and/or lipase >3 ULN at V4 (Week-1).

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

Endpoints (12)

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
8
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 24

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:From Baseline to Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in postprandial plasma glucose (PPG)

Time frame:From Baseline to Week 24

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From Baseline to Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in self-monitored plasma glucose (SMPG) profile

Time frame:From Baseline to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Patients with HbA1c <7.0%

Time frame:At Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Patients with HbA1c ≤ 6.5%

Time frame:At Week 24

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Patients with HbA1c <7.0% with no body weight gain

Time frame:At Week 24

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 24

threshold achievement, improvement

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

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Confirmed hypoglycemia

Time frame:From Baseline to Week 24

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:From Baseline to Week 24

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 24

Immunogenicity (ADA)

descriptive

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.