DelfaGLP-1 Atlas

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CompletedPhase 1

A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)

Randomized, Double-blind, Placebo-controlled, Dose Escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin and/or Basal Insulin

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

11

Recruiting sites

—

Enrollment

23

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•HbA1c 6.5-11%•Age 10-17

Primary endpoints

•Treatment-emergent AEs (any)•Immunogenicity (ADA)

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 IDNCT02803918
Org study IDTDR14311
Secondary IDU1111-1176-6142UTN

Timeline

Milestones

Study first posted2016-06-17estimated
Study start2017-05-17actual
Primary completion2020-01-27actual
Study completion2020-01-27actual
Last update posted2022-04-25actual

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years
Maximum age17 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female patients aged ≥10 and <18 years old (at least 4 patients below 16 years old).
•Body mass index (BMI) >85th percentile for age and gender; BMI ≤50 kg/m2.
•Male and female patients with documented T2DM insufficiently controlled with metformin at a stable dose and regimen for 8 weeks prior to randomization and/or basal insulin at stable dose (± 20%) and regimen for 8 weeks prior to randomization. The exact individual metformin dose will be selected according to local regulation and to the investigator's medical judgment.
•Glycated hemoglobin (HbA1c) >6.5% and ≤11% at screening.

Exclusion criteria

•If female, ongoing pregnancy (defined as positive serum pregnancy test), breast-feeding.
•Sexually active postmenarchal female patient who does not agree to use an adequate and highly effective method of contraception throughout the study duration and according to local regulation (ie, hormonal contraception, condom, etc.).
•Diabetes other than T2DM.
•Fasting plasma glucose >250 mg/dL (>13.9 mmol/L) at screening.
•Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin and basal insulin (eg, alpha glucosidase inhibitor, glucagon-like peptide (GLP-1) receptor agonist, dipeptidyl peptidase-IV (DPP-IV) inhibitors, short-acting insulin etc.) within 1 month prior to the screening visit.
•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.

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

Endpoints (9)

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

Safety / tolerability / PK
8
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Assessment of pharmacodynamic parameter: plasma glucose AUC-0-4.5 hours

Time frame:Day 14, Day 28 and Day 42

Postprandial glucose

concentration, descriptive

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

Number of patients with adverse events (AEs)

Time frame:Up to 10 weeks

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of patients with treatment-emergent adverse events (TEAEs)

Time frame:Up to 10 weeks

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of patients with anti-lixisenatide antibodies

Time frame:Up to 10 weeks

Immunogenicity (ADA)

event count, descriptive

Secondary/protocol endpoint

Assessment of pharmacokinetic (PK) parameters: lixisenatide plasma concentration

Time frame:Day 14, Day 28 and Day 42

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Assessment of PK parameters: maximum concentration (Cmax)

Time frame:Day 42

Cmax

concentration, descriptive

Secondary/protocol endpoint

Assessment of PK parameters: time to reach Cmax (Tmax)

Time frame:Day 42

Tmax

descriptive

Secondary/protocol endpoint

Assessment of PK parameters: area under up to last concentration (AUClast)

Time frame:Day 42

concentration, descriptive

Secondary/protocol endpoint

Assessment of PK parameters: area under curve (AUC)

Time frame:Day 42

AUC₀–∞

concentration, 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.