LIXILAN JP-L

CompletedPhase 3

Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine With Metformin in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

122

Recruiting sites

—

Enrollment

513

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 IDNCT02752412

Org study IDEFC14113

Secondary IDU1111-1176-8378UTN

Timeline

Milestones

Study first posted2016-04-27estimated

Study start2016-05-17actual

Primary completion2018-10-04actual

Study completion2018-10-04actual

Last update posted2020-06-16actual

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 (V1).

•Patient treated with a stable, once a day basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit.

•The total daily basal insulin dose should be stable (± 20%) and <15 U/day for at least 1 month before the screening visit.

•Patient receiving 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of:

•Metformin;

•Sulfonylurea (SU);

•Glinide;

•Dipeptidyl-peptidase-4 (DPP-4) inhibitor;

•Sodium glucose co-transporter 2 (SGLT2) inhibitor;

•Alpha glucosidase inhibitor (alpha-GI).

•Signed written informed consent.

Exclusion criteria

•Age <20 years at screening visit.

•HbA1c at screening visit <7.5% or >9.5%.

•Fasting plasma glucose (FPG) >180 mg/dL (10.0 mmol/L) at screening visit.

•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 in the 3 months before screening visit.

•Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin.

Note: Short-term treatment (≤10 days) due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator.

•Use of thiazolidinedione (TZD) within 6 months prior to screening visit.

•History of discontinuation of a previous treatment with a glucagon-like peptide-1(GLP-1) receptor agonist due to safety/ tolerability issues or lack of efficacy.

•Laboratory findings at the screening visit; including:

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

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

•Calcitonin ≥20 pg/mL (5.9 pmol/L);

•Positive serum pregnancy test.

•Any contraindication to metformin use according to local labeling.

•History of hypersensitivity to any GLP-1 receptor agonist or to metacresol.

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

•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 now been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.

•Exclusion criteria for randomization at the end of the run-in phase:

•HbA1c <7.5% or >9.5% at visit 6 (Week -1).

•Mean fasting self monitored plasma glucose (SMPG) >160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization.

Note:fasting SMPG on the day of randomization can be included if assessed before randomization.

•Average insulin glargine daily dose ≥15 U/day or <5U/day calculated for the last 3 days before Visit 7.

•Metformin total daily dose <750 mg/day.

•Amylase and/or lipase >3 ULN at Visit 6 (Week -1).

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

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

10 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 2-hour postprandial plasma glucose (PPG) during standardized meal test

Time frame:Baseline, 26 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in blood glucose excursion during standardized meal test

Time frame:Baseline, 26 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in 7-point self-monitoring plasma glucose (SMPG) profiles (each time point and average daily value)

Time frame:Baseline, 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in FPG

Time frame:Baseline, 26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

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

Secondary/protocol endpoint

Percentage of patients reaching HbA1c <7% with no body weight gain and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia

Time frame:26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Secondary/protocol endpoint

Percentage of patients reaching HbA1c <7% with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia

Time frame:26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of patients requiring a rescue therapy

Time frame:26 weeks

threshold achievement, event

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of hypoglycemic events

Time frame:26 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of adverse events

Time frame:26 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Measurement of anti-lixisenatide antibodies from baseline

Time frame:Baseline, 26 weeks

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint/low confidence

Measurement of anti-insulin antibodies from baseline

Time frame:Baseline, 26 weeks

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from baseline in daily dose of insulin glargine

Time frame:Baseline, 26 weeks

change from baseline, 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

iGlarLixi reduces residual hyperglycemia in Japanese patients with type 2 diabetes uncontrolled on basal insulin: A post-hoc analysis of the LixiLan JP-L trial.
Journal of diabetes investigation2021 Nov (month)PMID33945227doi:10.1111/jdi.13563via pubmed nct search
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 insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L randomized clinical trial.
Diabetes, obesity & metabolism2020 Sep (month)PMID32072742doi:10.1111/dom.14005via 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.