DelfaGLP-1 Atlas

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CompletedPhase 3

Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

An Open-Label, Multicenter 52-Week Study Assessing the Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

27

Recruiting sites

—

Enrollment

294

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 IDNCT01940965
Org study IDLTS12809
Secondary IDU1111-1129-8754UTN

Timeline

Milestones

Study first posted2013-09-12estimated
Last update posted2015-08-04estimated
Study start2013-09 (month precision)
Primary completion2015-07actual (month precision)
Study completion2015-07actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Patients with type 2 diabetes mellitus diagnosed at least 1 year before the screening visit
•Patient treated for at least 3 months prior to screening visit with one of following OADs at a stable dose of at least usual maintenance dose as described in the label
–a biguanide (metformin hydrochloride);
–a thiazolidinedione (TZD) (pioglitazone hydrochloride);
–an alpha-glucosidase inhibitor (alpha-GI) (acarbose, voglibose or miglitol);
–or a glinide (nateglinide, repaglinide or mitiglinide);
•Signed written informed consent

Exclusion criteria

•At screening HbA1c <7% or >9.5%;
•At screening: fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
•Use of any glucose-lowering agent(s) other than the authorized patient's background treatment defined in I02 (as given in inclusion critieria) within 3 months prior to screening;
•Type 1 diabetes mellitus;
•Women of childbearing potential with no effective contraceptive method;
•Pregnancy or lactation;
•Laboratory findings at the time of screening:
–Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN);
–ALT >3 ULN;
•Any contra-indication to the patient's background oral anti-diabetic treatment;
•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);
•Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP1 receptor agonist.

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 weeks 24 and 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 weeks 24 and 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Absolute change in fasting plasma glucose

Time frame:From baseline to weeks 24 and 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

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

Time frame:52 weeks

Treatment-emergent AEs (any)

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 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.