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LixiLan-L

CompletedPhase 3Results posted

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

236

Recruiting sites

—

Enrollment

736

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 IDNCT02058160

Org study IDEFC12405

Secondary ID2013-003132-79

Secondary IDU1111-1148-4351UTN

Timeline

Milestones

Study first posted2014-02-07estimated

Results first posted2017-02-10actual

Last update posted2017-05-09actual

Study start2014-01 (month precision)

Primary completion2015-07actual (month precision)

Study completion2015-07actual (month precision)

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

•Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.

•Treatment with basal insulin for at least 6 months before the screening visit.

•Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.

•Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.

•For participants receiving basal insulin and 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 could be 1 to 2 out of:

–metformin (more than or equal to 1500 mg/day or maximal tolerated dose),

–a sulfonylurea,

–a glinide,

–a dipeptidyl-peptidase-4 inhibitor,

–a sodium glucose co-transporter 2 inhibitor,

•Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for participants receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit.

•Signed written informed consent.

Exclusion criteria

•Age under legal age of adulthood at screening visit.

•HbA1c at screening visit less than 7.5% or above 10%.

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

•Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening.

•Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent illness is allowed.

•History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy.

•Participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide FRC or had previously received lixisenatide.

•Use of weight loss drugs within 3 months prior to screening visit.

•Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.

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

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

•Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.

•At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2.

•At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.

•At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.

•At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).

•Any contraindication to metformin use, according to local labeling, if the participant was taking metformin.

•Participant who had a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for participants, not treated with metformin.

Exclusion criteria for randomization:

•HbA1c less than 7% or above 10% .

•Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L).

•Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).

•Amylase and/or lipase more than 3 ULN .

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

Endpoints (15)

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

1 endpoint

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 30

Time frame:Baseline, Week 30

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	-0.67	—
Insulin Glargine	0.7	—

LS Mean Difference-1.3795% CI-1.808 – -0.93p<0.0001Mixed Models Analysis

Glycemic / diabetes

11 endpoints

Primary/protocol endpoint

Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30

Time frame:Baseline, Week 30

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	-1.13	—
Insulin Glargine	-0.62	—

Least square (LS) mean difference-0.5295% CI-0.633 – -0.397p<0.0001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio CombinationHbA1c <7.0%	54.9	—
HbA1c ≤ 6.5%	33.9	—
Insulin GlargineHbA1c <7.0%	29.6	—
HbA1c ≤ 6.5%	14.2	—

Difference in percentage25.5295% CI18.94 – 32.10p<0.0001Cochran-Mantel-Haenszel

Difference in percentage19.7695% CI13.90 – 25.62p<0.0001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30

Time frame:Baseline, Week 30

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	-3.9	—
Insulin Glargine	-0.47	—

LS Mean Difference-3.4395% CI-3.925 – -2.939p<0.0001ANCOVA

Secondary/protocol endpoint

Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30

Time frame:Baseline, Week 30

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	-1.5	—
Insulin Glargine	-0.6	—

LS Mean Difference-0.995% CI-1.154 – -0.64p<0.0001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30

Time frame:Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	34.2	—
Insulin Glargine	13.4	—

difference in percentage20.8295% CI14.98 – 26.66p<0.0001Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Change in Daily Insulin Glargine Dose From Baseline to Week 30

Time frame:Baseline, Week 30

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units (U)	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	10.64	—
Insulin Glargine	10.89	—

LS Mean Difference-0.2695% CI-1.762 – 1.246p0.7362Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

Time frame:Baseline up to Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	19.9	—
Insulin Glargine	9.0	—

Secondary/protocol endpoint

Change in FPG From Baseline to Week 30

Time frame:Baseline, Week 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	-0.35	—
Insulin Glargine	-0.46	—

Secondary/protocol endpoint

Change in 2-hour PPG From Baseline to Week 30

Time frame:Baseline, Week 30

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	-4.72	—
Insulin Glargine	-1.39	—

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period

Time frame:Baseline up to Week 30

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	31.7	—
Insulin Glargine	18.6	—

Secondary/protocol endpoint

Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period

Time frame:Baseline up to Week 30

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	2.7	—
Insulin Glargine	6	—

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year

Time frame:First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), events per subject-year	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	3.03	—
Insulin Glargine	4.22	—

Secondary/protocol endpoint

Percentage of Participants With Documented Symptomatic Hypoglycemia

Time frame:First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	40	—
Insulin Glargine	42.5	—

Secondary/protocol endpoint

Percentage of Participants With Severe Symptomatic Hypoglycemia

Time frame:First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])

Severe hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination	1.1	—
Insulin Glargine	0.3	—

Publications (12)

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

Glycaemic target attainment in people with Type 2 diabetes treated with insulin glargine/lixisenatide fixed-ratio combination: a post hoc analysis of the LixiLan-O and LixiLan-L trials.
Diabetic medicine : a journal of the British Diabetic Association2020 Feb (month)PMID31365765doi:10.1111/dme.14094via pubmed nct search
Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2020 Jan (month)PMID31848983doi:10.1007/s13300-019-00735-7via clinicaltrials gov reference derived + pubmed nct search
EFFICACY AND SAFETY OF IGLARLIXI IN HISPANICS AND NON-HISPANIC WHITES WITH TYPE 2 DIABETES.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2019 Nov (month)PMID31241362doi:10.4158/EP-2018-0615via pubmed nct search
Clinical Characteristics and Glycemic Outcomes of Patients with Type 2 Diabetes Requiring Maximum Dose Insulin Glargine/Lixisenatide Fixed-Ratio Combination or Insulin Glargine in the LixiLan-L Trial.
Advances in therapy2019 Sep (month)PMID31359368doi:10.1007/s12325-019-01033-1via clinicaltrials gov reference derived + pubmed nct search
Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes.
Current medical research and opinion2019 Jun (month)PMID30550345doi:10.1080/03007995.2018.1558852via clinicaltrials gov reference derived + pubmed nct search
Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world.
BMJ open diabetes research & care2019 (year)PMID31114694doi:10.1136/bmjdrc-2018-000581via clinicaltrials gov reference derived + pubmed nct search
Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes.
Diabetes, obesity & metabolism2018 Dec (month)PMID29974618doi:10.1111/dom.13462via clinicaltrials gov reference derived + pubmed nct search
Low incidence of gastrointestinal adverse events over time with a fixed-ratio combination of insulin glargine and lixisenatide versus lixisenatide alone.
Diabetes, obesity & metabolism2018 Nov (month)PMID29923298doi:10.1111/dom.13444via clinicaltrials gov reference derived + pubmed nct search
Bedtime-to-Morning Glucose Difference and iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of LixiLan-L.
Diabetes therapy : research, treatment and education of diabetes and related disorders2018 Oct (month)PMID30218434doi:10.1007/s13300-018-0507-0via clinicaltrials gov reference derived + pubmed nct search
iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L.
Diabetes therapy : research, treatment and education of diabetes and related disorders2018 Feb (month)PMID29143919doi:10.1007/s13300-017-0336-6via clinicaltrials gov reference derived + pubmed nct search
Consistent findings in glycaemic control, body weight and hypoglycaemia with iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) vs insulin glargine across baseline HbA1c, BMI and diabetes duration categories in the LixiLan-L trial.
Diabetes, obesity & metabolism2017 Oct (month)PMID28386990doi:10.1111/dom.12961via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial.
Diabetes care2016 Nov (month)PMID27650977doi:10.2337/dc16-1495via 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 tableClinicalTrials.gov results section

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.