GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

An Open-label, Randomized, Three-parallel-group Study on Pharmacodynamic Effects of 8-week QD Treatment With Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin

Lead sponsor

Sanofi

Assets

Liraglutide / Lixisenatide

Listed sites

Recruiting sites

—

Enrollment

142

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 20-40•HbA1c 6.5-9.5%

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 IDNCT01596504

Org study IDPDY12625

Secondary ID2012-000027-40

Secondary IDU1111-1124-1364UTN

Timeline

Milestones

Study first posted2012-05-11estimated

Last update posted2016-10-14estimated

Results first posted2016-10-14estimated

Study start2012-05 (month precision)

Primary completion2013-07actual (month precision)

Study completion2013-07actual (month precision)

Assets

Investigational agents

Liraglutide Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants with T2DM diagnosed at least 1 year before the screening visit.

•Treatment with neutral protamine hagedorn (NPH) or insulin glargine for at least 3 months and at a stable dose (±20%) of at least 10 IU/day (for at least 2 months prior to screening) alone or combined with a stable dose of metformin with or without dipeptidyl peptidase 4 (DPP-4) inhibitor or sulfonylurea.

•Glycosylated hemoglobin (HbA1c) ≥6.5 and ≤9.5%.

•Body mass index (BMI) between 20 and 40 kg/m^2.

Exclusion criteria

•Pregnant women or breastfeeding women.

•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 participation in a previous study with lixisenatide (AVE0010), and any previous treatment with liraglutide stopped for safety concern or lack of efficacy.

•Allergic reaction to any glucagon-like peptide-1 (GLP-1) agonist in the past (eg, 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.

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

Endpoints (34)

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

Weight & body composition

Cardiometabolic biomarkers

Other clinical outcomes

Patient-reported / QoL

Other (unclassified)

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline to Day 57 in Body Weight

Time frame:0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lixisenatide 20 µg	-1.61	—
Liraglutide 1.2 mg	-1.78	—
Liraglutide 1.8 mg	-2.42	—

Secondary/registry result

Change From Baseline to Day 57 in Waist Circumference

Time frame:0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Lixisenatide 20 µg	-1.40	—
Liraglutide 1.2 mg	-1.93	—
Liraglutide 1.8 mg	-2.12	—

Secondary/protocol endpoint

Change From Baseline to Day 57 in Body Weight

Time frame:0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Day 57 in Waist Circumference

Time frame:0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

20 endpoints

Primary/registry result

Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours

Time frame:0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), h*mmol/L	95% CI
Lixisenatide 20 μg	-13.33	—
Liraglutide 1.2 mg	-7.32	—
Liraglutide 1.8 mg	-8.72	—

Least squares (LS) mean difference-6.01p<0.0001Linear fixed effects model

LS mean difference-4.61p<0.0001Linear fixed effects model

Primary/protocol endpoint

Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours

Postprandial glucose

change from baseline, improvement

Secondary/registry result

Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours

Time frame:0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), h*mmol/L	95% CI
Lixisenatide 20 µg	-13.82	—
Liraglutide 1.2 mg	-9.09	—
Liraglutide 1.8 mg	-10.33	—

Secondary/registry result

Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56

Time frame:Day 56

Postprandial glucose

threshold achievement, improvement

Posted result

Group	Value (number), participants	95% CI
Lixisenatide 20 µg	35	—
Liraglutide 1.2 mg	13	—
Liraglutide 1.8 mg	11	—

Secondary/registry result

Change From Baseline to Day 56 in PPG Excursion

Time frame:0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide 20 µg	-3.26	—
Liraglutide 1.2 mg	-1.79	—
Liraglutide 1.8 mg	-2.5	—

Secondary/registry result

Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)

Time frame:0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide 20 µg	0.1	—
Liraglutide 1.2 mg	0.12	—
Liraglutide 1.8 mg	0.13	—

Secondary/registry result

Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)

Time frame:Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Lixisenatide 20 µg	-0.69	—
Liraglutide 1.2 mg	-0.76	—
Liraglutide 1.8 mg	-1.2	—

Secondary/registry result

Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours

Time frame:0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

C-peptide AUC

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), h*nmol/L	95% CI
Lixisenatide 20 µg	-1.16	—
Liraglutide 1.2 mg	1.23	—
Liraglutide 1.8 mg	0.88	—

Secondary/registry result

Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours

Time frame:0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), h*ng/L	95% CI
Lixisenatide 20 µg	-16.56	—
Liraglutide 1.2 mg	11.58	—
Liraglutide 1.8 mg	5.6	—

Secondary/registry result

Change From Baseline to Day 56 in HbA1c

Time frame:Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Lixisenatide 20 µg	-0.58	—
Liraglutide 1.2 mg	-0.66	—
Liraglutide 1.8 mg	-0.74	—

Secondary/registry result

Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose

Time frame:Day -7 (Baseline), Day 56

change from baseline, improvement

Posted result

Group	Value (mean), units	95% CI
Lixisenatide 20 µg	-4.7	—
Liraglutide 1.2 mg	-4.6	—
Liraglutide 1.8 mg	-4.0	—

Secondary/protocol endpoint

Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56

Time frame:Day 56

Postprandial glucose

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline to Day 56 in PPG Excursion

Time frame:0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)

Time frame:0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)

Time frame:Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours

Time frame:0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Day 56 in HbA1c

Time frame:Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose

Time frame:Day -7 (Baseline), Day 56

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints

Secondary/registry result

Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate

Time frame:Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute	95% CI
Lixisenatide 20 µg	3.34	—
Liraglutide 1.2 mg	9.33	—
Liraglutide 1.8 mg	9.17	—

Secondary/registry result

Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure

Time frame:Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58

Systolic BP, change

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Lixisenatide 20 µg24-Hour Mean Systolic Blood Pressure	0.4	—
24-Hour Mean Diastolic Blood Pressure	0.8	—
Liraglutide 1.2 mg24-Hour Mean Systolic Blood Pressure	-0.5	—
24-Hour Mean Diastolic Blood Pressure	2.4	—
Liraglutide 1.8 mg24-Hour Mean Systolic Blood Pressure	-2.5	—
24-Hour Mean Diastolic Blood Pressure	1.6	—

Secondary/protocol endpoint

Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate

Time frame:Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure

Time frame:Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Patient-reported / QoL

2 endpoints

Secondary/registry result

Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast

Time frame:0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56

change from baseline, improvement

Posted result

Group	Value (mean), mm	95% CI
Lixisenatide 20 µgHow hungry do you feel?	-3.7	—
How satisfied do you feel?	4.5	—
How full do you feel?	4.9	—
How much do you think you can eat?	-6.4	—
Liraglutide 1.2 mgHow hungry do you feel?	-3.1	—
How satisfied do you feel?	8.9	—
How full do you feel?	9.3	—
How much do you think you can eat?	-4.5	—
Liraglutide 1.8 mgHow hungry do you feel?	-1.0	—
How satisfied do you feel?	3.6	—
How full do you feel?	6.4	—
How much do you think you can eat?	-7.2	—

Secondary/protocol endpoint

Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast

change from baseline, improvement

Other clinical outcomes

3 endpoints

Secondary/registry result

Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)

Time frame:0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55

change from baseline, descriptive

Posted result

Group	Value (least_squares_mean), minutes (min)	95% CI
Lixisenatide 20 µg	453.56	—
Liraglutide 1.2 mg	175.31	—
Liraglutide 1.8 mg	130.49	—

Secondary/registry result

Change From Baseline to Day 55 in Gastric Emptying Coefficient

Time frame:0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55

change from baseline, descriptive

Posted result

Group	Value (mean), coefficient (unit-less)	95% CI
Lixisenatide 20 µg	-0.33	—
Liraglutide 1.2 mg	-0.34	—
Liraglutide 1.8 mg	-0.28	—

Secondary/protocol endpoint/low confidence

Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)

Time frame:0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change From Baseline to Day 55 in Gastric Emptying Coefficient

Time frame:0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55

change from baseline, 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

Contrasting Effects of Lixisenatide and Liraglutide on Postprandial Glycemic Control, Gastric Emptying, and Safety Parameters in Patients With Type 2 Diabetes on Optimized Insulin Glargine With or Without Metformin: A Randomized, Open-Label Trial.
Diabetes care2015 Jul (month)PMID25887358doi:10.2337/dc14-1984via 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.