DelfaGLP-1 Atlas

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CompletedPhase 3

Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

An Open-label, Multicenter 24-Week And 52-Week Study Assessing The Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

30

Recruiting sites

—

Enrollment

361

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT01960179
Org study IDSFY13476
Secondary IDU1111-1134-2695UTN

Timeline

Milestones

Study first posted2013-10-10estimated
Last update posted2015-04-09estimated
Study start2013-11 (month precision)
Primary completion2015-03actual (month precision)
Study completion2015-03actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Patients with type 2 diabetes mellitus diagnosed for at least 2 months.
•Not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (OAD) for at least 3 months prior to screening visit. Previous OAD (if any) have to be stopped at Visit 1.1 to be washed out during the run-in period at least for 6 weeks;
•Signed written informed consent.

Exclusion criteria

•At screening
•age <20 years;
•HbA1c <7% or >9.5% (for patients on OAD <6.5% or >8.5%);
•fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
•Use of more than one OAD within 3 months prior to screening;
•Use of Thiazolidinedione (TZD) within 6 months prior to screening;
•Use of insulin within 3 months prior to screening; Note: Short time use (≤10 days) of insulin due to acute illness or surgery (eg, infectious disease) is allowed.
•Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP-1 receptor agonist;
•Type 1 diabetes mellitus
•Women of childbearing potential with no effective contraceptive method;
•Pregnancy or lactation;
•Laboratory findings at the time of screening:

oAmylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN);

•ALT >3 ULN;
•Calcitonin ≥20 pg/mL (5.9 pmol/L);
•Positive serum pregnancy test in women of childbearing potential;
•History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease;
•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes);
•Allergic reaction to metacresol.

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

Endpoints (4)

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
2
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Absolute change in body weight

Time frame:from baseline to week 24 and week 52

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Absolute change in HbA1c

Time frame:from baseline to week 24 and week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Absolute change in fasting plasma glucose

Time frame:from baseline to week 24 and week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.

Time frame:from baseline to 24 weeks and 52 weeks

Treatment-emergent AEs (any)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.