LIXILAN JP-O1

CompletedPhase 3

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

321

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 IDNCT02749890

Org study IDEFC14112

Secondary IDU1111-1176-8357UTN

Timeline

Milestones

Study first posted2016-04-25estimated

Study start2016-05-09actual

Last update posted2020-06-16actual

Primary completion2018-05actual (month precision)

Study completion2018-05actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be biguanide, thiazolidinedione, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor.

•Signed written informed consent.

Exclusion criteria

•At the screening visit: age <20 years.

•At the screening visit: HbA1c <7.5% or >10%.

•At the screening visit: fasting plasma glucose (FPG) >250 mg/dL (13.8 mmol/L).

•Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.

•Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria during the 3 months before the screening visit.

•Previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician).

•Laboratory findings at the screening visit, including:

•Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN),

•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN,

•Calcitonin ≥20 pg/mL (5.9 pmol/L),

•Positive serum pregnancy test.

•Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any glucagon-like peptide-1 receptor agonist (GLP-1RA) or to metacresol.

•Contraindication to use of insulin glargine according to the local labeling. History of hypersensitivity to insulin glargine or to any of the excipients.

•Patient who has a severe renal function impairment with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2 or end-stage renal disease for patient not treated with metformin.

•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).

•History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.

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

Safety / tolerability / PK

Weight & body composition

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Baseline, 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change from baseline in HbA1c

Time frame:Baseline, 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of patients reaching HbA1c <7% or ≤6.5%

Time frame:26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in fasting plasma glucose

Time frame:Baseline, 26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in from baseline in 7 point self-monitored plasma profiles

Time frame:Baseline, 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Percentage of patients reaching HbA1c <7% with no body weight gain

Time frame:26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Percentage of patients requiring a rescue therapy

Time frame:26 weeks

threshold achievement, event

Secondary/protocol endpoint

Number of hypoglycemic events

Time frame:26 weeks, 52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of adverse events

Time frame:26 weeks, 52 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Measurement of anti-lixisenatide antibodies from baseline

Time frame:Baseline, 26 weeks, 52 weeks

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Measurement of anti-insulin antibodies from baseline

Time frame:Baseline, 26 weeks, 52 weeks

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in daily dose of insulin glargine for the combination group

Time frame:Day 1, 26 weeks

change from baseline, 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

Benefits of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide (iGlarLixi) in Japanese people with type 2 diabetes: A subgroup and time-to-control analysis of the LixiLan JP phase 3 trials.
Diabetes, obesity & metabolism2020 Sep (month)PMID33404200doi:10.1111/dom.14139via pubmed nct search
Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial.
Diabetes care2020 Jun (month)PMID32295808doi:10.2337/dc19-2452via CT.gov reference + pubmed nct search

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.