DelfaGLP-1 Atlas

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LixiLan-G

CompletedPhase 3Results posted

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period

Lead sponsor

Sanofi

Assets

Albiglutide / Dulaglutide / Exenatide / GLP-1 / incretin class catch-all / Liraglutide / Lixisenatide

Listed sites

124

Recruiting sites

—

Enrollment

514

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 IDNCT02787551
Org study IDEFC13794
Secondary ID2014-004850-32
Secondary IDU1111-1168-4639UTN

Timeline

Milestones

Study first posted2016-06-01estimated
Study start2016-07-06actual
Primary completion2018-05-25actual
Study completion2018-11-17actual
Results first posted2019-06-12actual
Last update posted2022-03-25actual

Assets

Investigational agents

AlbiglutideDulaglutideExenatideGLP-1 / incretin class catch-allLiraglutideLixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Participants with type 2 diabetes mellitus diagnosed at least 1 year prior to screening visit.
•Participants who were treated with one of the following GLP-1 receptor agonists for at least 4 months prior to screening visit 1 (V1), and with stable dose for at least 3 months prior to screening visit (V1):
•Liraglutide (Victoza®) 1.8 milligram (mg) QD or 1.2 mg QD, if the 1.8 mg QD dose was not well tolerated according to the Investigator's judgment or
•Exenatide (Byetta®) 10 microgram (µg) BID or of 5 µg BID, if 10 µg BID dose was not well tolerated according to the Investigator's judgment

in combination with metformin (daily dose greater than equal to [>=] 1500 mg/day or maximum tolerated dose [MTD]), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening.

or

Participants who were treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):

•Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator's judgment,
•Albiglutide (Tanzeum®) 50 mg QW or 30 mg QW, if 50 mg QW was not well tolerated according to Investigator's judgment,
•Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW was not well tolerated according to Investigator's judgment

in combination with metformin (daily dose ≥1500 mg/day or MTD), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening;

-Signed written informed consent.

Exclusion criteria

•At screening visit, age <18.
•Screening HbA1c <7% and >9%.
•Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
•Any use of antidiabetic drugs within 3 months prior to the screening visit other than those described in the inclusion criteria.
•Previous treatment with insulin in the year prior to screening visit (note: short-term treatment with insulin [<=10 days] due to intercurrent illness including gestational diabetes was allowed at the discretion of the study physician).
•Laboratory findings at the time of screening, including:
•Fasting plasma glucose (FPG) >250 mg/dL (13.9 millimoles per litre [mmol/L]),
•Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN),
•Alanine transaminase or aspartate transaminase >3 ULN,
•Calcitonin >=20 pg/mL (5.9 pmol/L),
•Positive pregnancy test.
•Participant who had renal function impairment with estimated glomerular filtration rate <30mL/min/1.73m^2 (using the Modification of Diet in Renal Disease formula) or end-stage renal disease.
•Contraindication to use of insulin glargine, or lixisenatide or GLP-1 receptor agonist (Victoza®, Byetta®, Bydureon®, Tanzeum® or Trulicity®) according to local labeling.
•Any contraindication to metformin or pioglitazone or SGLT2 inhibitor use, according to local labeling.
•History of hypersensitivity to insulin glargine, or to any of the excipients.
•History of allergic reaction to any GLP-1 receptor agonist or to meta-cresol.
•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia type 2 syndromes).
•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.
•Body mass index <=20 or >40 kg/m^2.

Exclusion criteria for the extension period:

•Participants in the FRC arm with a rescue therapy and HbA1c >8% at week 22.
•Participants in the FRC arm who discontinued prematurely from FRC treatment before week 26.
•Participants in the GLP-1 RA treatment arm after randomization.

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

Endpoints (36)

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
27
Safety / tolerability / PK
5
Weight & body composition
4

Weight & body composition

4 endpoints
Secondary/registry result

Change From Baseline in Body Weight at Week 26: Core Period

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilogram (kg)95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)1.89—
GLP-1 Receptor Agonist-1.14—
Secondary/registry result

Change From Baseline in Body Weight to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)2.78—
Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 26: Core Period

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

27 endpoints
Primary/registry result

Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of HbA1c95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-1.02—
GLP-1 Receptor Agonist-0.38—
Least square (LS) mean difference-0.6495% CI-0.770 – -0.508p<0.0001Mixed Models Analysis
Primary/registry result

Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percentage of HbA1c95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-1.01—
Primary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)HbA1c <7%61.9—
HbA1c <=6.5%40.5—
GLP-1 Receptor AgonistHbA1c <7%25.7—
HbA1c <=6.5%9.9—
Difference in percentage36.0595% CI28.11 – 43.99p<.0001Cochran-Mantel-Haenszel
Secondary/registry result

Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)HbA1c <7%64.1—
HbA1c <=6.5%42.7—
Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), millimoles per litre (mmol/L)95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-2.28—
GLP-1 Receptor Agonist-0.60—
LS Mean Difference-1.6795% CI-2.001 – -1.341p<0.0001Mixed Models Analysis
Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-2.27—
Secondary/registry result

Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period

Time frame:Baseline, Week 26

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-1.69—
GLP-1 Receptor Agonist-0.67—
LS Mean Difference-1.0295% CI-1.325 – -0.708p<0.0001Mixed Models Analysis
Secondary/registry result

Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

GroupValue (mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-1.68—
Secondary/registry result

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-3.96—
GLP-1 Receptor Agonist-1.11—
LS Mean Difference-2.8595% CI-3.420 – -2.279p<0.0001ANCOVA
Secondary/registry result

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-4.30—
Secondary/registry result

Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-1.51—
GLP-1 Receptor Agonist-0.52—
LS Mean Difference-0.9995% CI-1.468 – -0.508p<0.0001ANCOVA
Secondary/registry result

Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)-1.85—
Secondary/registry result

Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period

Time frame:From Baseline to Week 26

threshold achievement, event

Posted result

GroupValue (number), percentage of participants95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)4.8—
GLP-1 Receptor Agonist15.0—
Secondary/registry result

Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period

Time frame:From Week 26 to Week 52

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)1.5—
Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period

Time frame:Week 52

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 (FPG) to Week 26: Core Period

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period

Time frame:Baseline, Week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period

Time frame:From Baseline to Week 26

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

5 endpoints
Secondary/registry result

Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period

Time frame:From Baseline to Week 26

Documented hypoglycemia

event count, event

Posted result

GroupValue (number), events per participant-year95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)Documented symptomatic hypoglycemia(<=3.9 mmol/L)1.54—
Documented symptomatic hypoglycemia (<3.0 mmol/L)0.25—
GLP-1 Receptor AgonistDocumented symptomatic hypoglycemia(<=3.9 mmol/L)0.08—
Documented symptomatic hypoglycemia (<3.0 mmol/L)0.01—
Secondary/registry result

Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period

Time frame:From Baseline to Week 52

Documented hypoglycemia

event count, event

Posted result

GroupValue (number), events per participant-year95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)Documented symptomatic hypoglycemia(<=3.9 mmol/L)1.59—
Documented symptomatic hypoglycemia (<3.0 mmol/L)0.24—
Secondary/protocol endpoint

Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period

Time frame:From Week 26 to Week 52

threshold achievement, event

Secondary/protocol endpoint

Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period

Time frame:From Baseline to Week 26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period

Time frame:From Baseline to Week 52

Documented hypoglycemia

event count, event

Publications (5)

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 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.