GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Paediatric (10 - 17 Years Old) and Adult Patients With Type 2 Diabetes

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT01572649

Org study IDPKD11475

Secondary ID2011-004584-67

Secondary IDU1111-1124-3136UTN

Timeline

Milestones

Study first posted2012-04-06estimated

Last update posted2014-05-23estimated

Study start2012-05 (month precision)

Primary completion2014-03actual (month precision)

Study completion2014-03actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose ≥ 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year (adults) and at least 3 months for paediatric population at the time of screening visit, with or without metformin (stable dose ± 10 % for at least 4 weeks prior to randomization)

•HbA1c ≥ 7% and ≤ 10% at screening

•Age eligibility for paediatric population: ≥ 10 years and <18 years with at least 3 patients below 15 years and no more than 3 patients aged between 16 and 18 years; Age eligibility for adults: ≥ 18 and ≤ 65 years

•For paediatric population:body weight >50kg, BMI >85th percentile for age and gender and BMI ≤ 50 kg/m²

•For adults: BMI > 25 kg/m2 and ≤ 37 kg/m2

Exclusion criteria

•If female, pregnancy (defined as positive serum pregnancy test), breast-feeding

•Diabetes other than type 2 diabetes

•Positive test for insulinoma associated protein (IA2) and glutamic acid decarboxylase (GAD) autoantibodies

•Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening

•Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide, liraglutide) 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 genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes)

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

Endpoints (7)

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

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value

Time frame:D1 at each period up to 4h30 after study drug injection (8 timepoints)

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection) until 4 hours later for insulin, C-peptide and glucagon

Time frame:D1 at each period up to 4h30 after study drug injection (7 timepoints)

C-peptide AUC

descriptive

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Pharmacokinetics: lixisenatide plasma concentration

Time frame:0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints)

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic parameter (Cmax)

Time frame:calculated over the period of timepoints at D1 of each study period

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic parameter (Tmax)

Time frame:calculated over the period of timepoints at D1 of each study period

Tmax

descriptive

Secondary/protocol endpoint

Pharmacokinetic parameter (AUC last)

Time frame:estimated over the period of timepoints at D1 of each study period

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic parameter (AUC)

Time frame:extrapolated based on the period of timepoints at D1 of each study period

AUC₀–∞

concentration, 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.