DelfaGLP-1 Atlas

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CompletedPhase 2Results posted

Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

An Open-label, Randomized Two-arm Parallel Group Study to Compare the Effects of 4-week QD Treatment With Lixisenatide or Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Lead sponsor

Sanofi

Assets

Liraglutide / Lixisenatide

Listed sites

7

Recruiting sites

—

Enrollment

148

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Postprandial glucose

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 IDNCT01175473
Org study IDPDY10931
Secondary ID2009-017666-23
Secondary IDU1111-1116-9040UTN

Timeline

Milestones

Study first posted2010-08-04estimated
Results first posted2016-10-11estimated
Last update posted2016-11-28estimated
Study start2010-08 (month precision)
Primary completion2010-11actual (month precision)
Study completion2010-11actual (month precision)

Assets

Investigational agents

LiraglutideLixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age74 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus diagnosed for at least 1 year at the time of screening visit, not adequately controlled by metformin at a dose of at least 1.5 gram per day for at least 3 months prior to screening
•HbA1c greater than or equal to (>=) 6.5% (as recommended by the American Diabetes Association) and HbA1c less than or equal to (<=) 9% at screening
•Covered by Health Insurance System where applicable and/or in compliance with the recommendations of the National (German) Law in force relating to biomedical research
•Not under any administrative or legal supervision

Exclusion criteria

•At the time of screening age <18 years or >=75 years
•Body Mass Index (BMI): <=20 kilogram per square meter (kg/m^2) or >=37 kg/m^2
•History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
•Hemoglobinopathy or hemolytic anemia
•History of myocardial infarction, stroke, or heart failure requiring hospitalization within 6 months prior to the time of screening, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period
•Cardiovascular, hepatic, neurological, or endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult (euthyroid patients on replacement therapy are to be included if the dosage of thyroxin is stable for at least 3 months prior to the screening visit)
•Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure >160 millimeter of mercury (mmHg) or >95 mmHg, respectively
•Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening that in the judgment of the investigator or any sub-investigator precludes safe completion of the study
•Receipt of blood or plasma products within 3 months prior to the time of screening
•Investigator or any sub-investigator, pharmacist, study coordinator, or their study staff or relative thereof directly involved in the conduct of the protocol
•Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility of meeting specific protocol requirements such as scheduled visits, being unable to do self-injections, etc.)
•Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (for example, alpha glucosidase inhibitor, exenatide, dipeptidyl peptidase IV [DPP-IV] inhibitors, insulin, thiazolidinedione, sulfonylurea, etc.) within 3 months prior to the time of screening
•Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening
•Likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol
•Use of any investigational drug within 3 months prior to screening
•Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening
•Any previous treatment with lixisenatide or liraglutide
•Allergic reaction to any glucagon like peptide - 1 (GLP-1) agonist in the past (for example, exenatide) or to metacresol
•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
•Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
•Known history of drug or alcohol abuse within 6 months prior to the time of screening
•Laboratory findings at the time of screening: alanine aminotransferase: >3 times the upper limit of the normal (ULN) laboratory range; calcitonin >=20 picogram per milliliter (pg/mL); amylase and lipase >3 times ULN; total bilirubin >1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100,000/mm^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody and Positive reaction to tests for anti-human immunodeficiency virus (HIV) type 1 (HIV1) and anti-HIV2 antibodies
•Renal impairment defined by creatinine clearance <60 milliliter per minute (mL/min) using the Cockcroft-Gault formula

Endpoints (20)

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
14
Cardiometabolic biomarkers
3
Other (unclassified)
3

Glycemic / diabetes

14 endpoints
Primary/registry result

Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), h*mg/dL95% CI
Lixisenatide-227.25-246.88 – -207.61
Liraglutide-72.83-93.19 – -52.46
Least squares (LS) Mean Difference-154.4295% CI-180.30 – -128.54p<0.0001Linear fixed effects model
Primary/protocol endpoint

Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Postprandial glucose

change from baseline, improvement

Secondary/registry result

Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mg/dL95% CI
Lixisenatide-70.43-77.83 – -63.03
Liraglutide-24.93-32.57 – -17.29
Secondary/registry result

Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), hour*micro international unit/milliliter95% CI
Lixisenatide-1.27-2.36 – -0.18
Liraglutide-2.47-3.59 – -1.34
Secondary/registry result

Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), hour*micro international unit/milliliter95% CI
Lixisenatide-64.22-78.20 – -50.24
Liraglutide5.34-9.16 – 19.84
Secondary/registry result

Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

C-peptide AUC

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), h*ng/mL95% CI
Lixisenatide-5.03-6.33 – -3.72
Liraglutide1.04-0.31 – 2.39
Secondary/registry result

Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

glucagon auc postprandial

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), h*pg/mL95% CI
Lixisenatide-46.71-61.60 – -31.83
Liraglutide-25.28-40.65 – -9.90
Secondary/registry result

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29

Time frame:Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of hemoglobin95% CI
Lixisenatide-0.32-0.40 – -0.24
Liraglutide-0.45-0.54 – -0.37
Secondary/protocol endpoint

Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29

Time frame:Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

3 endpoints
Secondary/registry result

Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28

change from baseline, descriptive

Posted result

GroupValue (mean), pmol/L95% CI
LixisenatideChange at Day 28: 0.5 h0.02—
Change at Day 28: 2.5 h-7.09—
Change at Day 28: 4.5 h-8.33—
LiraglutideChange at Day 28: 0.5 h-0.79—
Change at Day 28: 2.5 h-3.14—
Change at Day 28: 4.5 h-2.47—
Secondary/registry result

Change From Time-matched Baseline in Obestatin Concentration at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28

change from baseline, descriptive

Posted result

GroupValue (mean), nmol/L95% CI
LixisenatideChange at Day 28: 0.5 h0.04—
Change at Day 28: 2.5 h0.03—
Change at Day 28: 4.5 h-0.01—
LiraglutideChange at Day 28: 0.5 h0.02—
Change at Day 28: 2.5 h0.01—
Change at Day 28: 4.5 h-0.01—
Secondary/registry result

Percentages of Patients by Ranges of Oxyntomodulin Levels

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28

oxyntomodulin level categorical distribution

categorical status, descriptive

Posted result

GroupValue (number), percentage of participants95% CI
LixisenatideDay -1, 0.5 h: <=LOD (n = 75, 68)33.3—
Day -1, 0.5 h: LOD-LOQ (n = 75, 68)49.3—
Day -1, 0.5 h: >LOQ (n = 75, 68)17.3—
Day -1, 2.5 h: <=LOD (n = 75, 68)12.0—
Day -1, 2.5 h: LOD-LOQ (n = 75, 68)25.3—
Day -1, 2.5 h: >LOQ (n = 75, 68)62.7—
Day -1, 4.5 h: <=LOD (n = 75, 68)17.3—
Day -1, 4.5 h: LOD-LOQ (n = 75, 68)34.7—
Day -1, 4.5 h: >LOQ (n = 75, 68)48.0—
Day 28, 0.5 h: <=LOD (n = 75, 68)38.7—
Day 28, 0.5 h: LOD-LOQ (n = 75, 68)40.0—
Day 28, 0.5 h: >LOQ (n = 75, 68)21.3—
Day 28, 2.5 h: <=LOD (n = 74, 68)52.7—
Day 28, 2.5 h: LOD-LOQ (n = 74, 68)32.4—
Day 28, 2.5 h: >LOQ (n = 74, 68)14.9—
Day 28, 4.5 h: <=LOD (n = 75, 68)52.0—
Day 28, 4.5 h: LOD-LOQ (n = 75, 68)33.3—
Day 28, 4.5 h: >LOQ (n = 75, 68)14.7—
LiraglutideDay -1, 0.5 h: <=LOD (n = 75, 68)20.6—
Day -1, 0.5 h: LOD-LOQ (n = 75, 68)55.9—
Day -1, 0.5 h: >LOQ (n = 75, 68)23.5—
Day -1, 2.5 h: <=LOD (n = 75, 68)8.8—
Day -1, 2.5 h: LOD-LOQ (n = 75, 68)23.5—
Day -1, 2.5 h: >LOQ (n = 75, 68)67.6—
Day -1, 4.5 h: <=LOD (n = 75, 68)11.8—
Day -1, 4.5 h: LOD-LOQ (n = 75, 68)39.7—
Day -1, 4.5 h: >LOQ (n = 75, 68)48.5—
Day 28, 0.5 h: <=LOD (n = 75, 68)30.9—
Day 28, 0.5 h: LOD-LOQ (n = 75, 68)51.5—
Day 28, 0.5 h: >LOQ (n = 75, 68)17.6—
Day 28, 2.5 h: <=LOD (n = 74, 68)16.2—
Day 28, 2.5 h: LOD-LOQ (n = 74, 68)48.5—
Day 28, 2.5 h: >LOQ (n = 74, 68)35.3—
Day 28, 4.5 h: <=LOD (n = 75, 68)20.6—
Day 28, 4.5 h: LOD-LOQ (n = 75, 68)52.9—
Day 28, 4.5 h: >LOQ (n = 75, 68)26.5—

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change From Time-matched Baseline in Obestatin Concentration at Day 28

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Percentages of Patients by Ranges of Oxyntomodulin Levels

Time frame:0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28

threshold achievement, descriptive

Publications (1)

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.