GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

451

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 IDNCT01517412

Org study IDEFC12261

Secondary ID2011-002416-85

Secondary IDU1111-1118-0841UTN

Timeline

Milestones

Study first posted2012-01-25estimated

Last update posted2016-10-14estimated

Results first posted2016-10-14estimated

Study start2012-02 (month precision)

Primary completion2013-05actual (month precision)

Study completion2013-05actual (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

•Participants with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit

•Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.

Exclusion criteria

•Screening HbA1c < 7.0% and > 10.0%

•Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)

•Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin

•Participants who usually did not eat breakfast

•Type 1 diabetes mellitus

•Body Mass Index (BMI) ≤ 20 kg/m^2 and > 40 kg/m^2

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

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

•Alanine aminotransferase (ALT) > 3 ULN at screening

•Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening

•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.

•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)

•Any contra-indication related to metformin

•Any previous treatment with lixisenatide

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

Endpoints (10)

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

Patient-reported / QoL

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 24

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lixisenatide Main Meal	-2.60	—
Lixisenatide Breakfast	-2.80	—

Glycemic / diabetes

8 endpoints

Primary/protocol endpoint

Change in HbA1c From Baseline to Week 24

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of hemoglobin	95% CI
Lixisenatide Main Meal	-0.65	—
Lixisenatide Breakfast	-0.74	—

Least square (LS) mean difference0.0995% CI-0.067 – 0.242

LS Mean Difference0.09p0.2664ANCOVA

Secondary/protocol endpoint

Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Lixisenatide Main MealHbA1c <7%	43.6	—
HbA1c ≤6.5%	22.5	—
Lixisenatide BreakfastHbA1c <7%	42.8	—
HbA1c ≤6.5%	25.7	—

Secondary/protocol endpoint

Change in Average 7-point SMPG Profiles From Baseline to Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide Main Meal	-0.80	—
Lixisenatide Breakfast	-1.10	—

Secondary/protocol endpoint

Change in FPG From Baseline to Week 24

Time frame:Baseline, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide Main Meal	-0.35	—
Lixisenatide Breakfast	-0.57	—

Secondary/protocol endpoint

Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period

Time frame:Week 24

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

Posted result

Group	Value (number), Percentage of participants	95% CI
Lixisenatide Main Meal	40.4	—
Lixisenatide Breakfast	41.0	—

Secondary/protocol endpoint

Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24

Time frame:Week 24

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
Lixisenatide Main Meal	40.8	—
Lixisenatide Breakfast	38.6	—

Secondary/protocol endpoint

Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

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

LOINC 4548-4

Posted result

Group	Value (number), Percentage of participants	95% CI
Lixisenatide Main Meal	38.1	—
Lixisenatide Breakfast	37.2	—

Secondary/protocol endpoint

Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24

Time frame:Week 24

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Postprandial glucose

Posted result

Group	Value (number), Percentage of participants	95% CI
Lixisenatide Main Meal	28.9	—
Lixisenatide Breakfast	27.6	—

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	95% CI
Lixisenatide Main Meal	3.01	—
Lixisenatide Breakfast	3.54	—

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

Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day.
Journal of diabetes and its complications2014 Sep-Oct (year)PMID25012990doi:10.1016/j.jdiacomp.2014.05.012via CT.gov reference

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.